22. 510 (k) Number. K162081. Device Name. BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe. Applicant. Becton, Dickinson and Company. 1 Becton Drive. Franklin Lakes, NJ 07417.22. 510 (k) Number. K232880. Device Name. Inzii Ripstop Redeployable Retrieval System. Applicant. Applied Medical Resources Corporation. 22872 Avenida Empresa. Rancho Santa Margarita, CA 92688.510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... New Search: Back To Search Results: Device Classification Name: neurological stereotaxic instrument: 510(k) Number: K182417: Device Name: ROSA ONE Brain Application: Applicant: MEDTECH S.A. ZAC … Date Received: 12/23/2022: Decision Date: 10/13/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Anesthesiology 510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... TPLC : New Search: Back To Search Results: Device Classification Name: implant, eye valve: 510(k) Number: K220032: Device Name: iStent infinite Trabecular Micro-Bypass System, Model iS3: Applicant: …510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... Device Classification Name: brain injury adjunctive interpretive oculomotor assessment aid: 510(k) Number: K202927: Device Name: EYE-SYNC: Applicant: SyncThink, Inc. 2172 Staunton Court: Palo Alto, …510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... New Search: Back To Search Results: Device Classification Name: physiological signal based seizure monitoring system: 510(k) Number: K181861: Device Name: Embrace: Applicant: Empatica Srl: Via Stendhal …Mar 4, 2024 · 510 (k) Number. K222898. Device Name. SafeSource Direct Blue Powder-Free Nitrile Exam Gloves. Applicant. SafeSource Direct, LLC. 200 St Nazaire Rd. Broussard, LA 70518. Applicant Contact. Device Classification Name: intervertebral fusion device with bone graft, lumbar: 510(k) Number: K231680: Device Name: AccelFix Lumbar Expandable Cage SystemPhillips stressed that the premarket notification, or 510(k), process is a classification process, whereas PMA is a determination of safety and effectiveness that leads to approval. Thus, the programs cannot be directly compared. For devices in class I and class II, safety and effectiveness are ensured by conforming with all the general controls.A premarket notification, or 510 (k) submission, is the mechanism through which the majority of medical devices obtain U.S. marketing clearance. A 510 (k) submission is required for any device intended for human use unless the device is exempt by regulation (most Class I and select Class II devices) or is a Class III device. A 510 (k ...Mar 4, 2024 · 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA 510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA ... TPLC : New Search: Back To Search Results: Device Classification Name: electrosurgical, cutting & coagulation & accessories: 510(k) Number: K221743: Device Name: Radio Frequency …510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... CLIA | TPLC : New Search: Back To Search Results: Device Classification Name: solid state x-ray imager (flat panel/digital imager) 510(k) Number: K231959: Device Name: EXPD 4357; EXPD 4357P: …510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... TPLC : New Search: Back To Search Results: Device Classification Name: respiratory specimen nucleic acid sars-cov-2 test: 510(k) Number: K211079: Device Name: BioFire COVID-19 Test 2: Applicant: …510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... New Search: Back To Search Results: Device Classification Name: neurological stereotaxic instrument: 510(k) Number: K182417: Device Name: ROSA ONE Brain Application: Applicant: MEDTECH S.A. ZAC …Device Classification Name: system, image processing, radiological: 510(k) Number: K211257: Device Name: EFAI PACS Picture Archiving and Communication System510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... Back To Search Results: Device Classification Name: cranial electrotherapy stimulator to treat insomnia and/or anxiety: 510(k) Number: K230826: Device Name: Modius Sleep: Applicant: Neurovalens …When Is a 510(k) Premarket Notification Necessary? In general, Class II medical devices need to be cleared through the 510(k) process. Most Class I devices are exempt from the 510(k) and premarket approval (PMA) processes, and most Class III devices need a PMA. More specifically, a 510(k) premarket notification submission is …Phillips stressed that the premarket notification, or 510(k), process is a classification process, whereas PMA is a determination of safety and effectiveness that leads to approval. Thus, the programs cannot be directly compared. For devices in class I and class II, safety and effectiveness are ensured by conforming with all the general controls.Device Classification Name: apparatus, cutting, radiofrequency, electrosurgical, battery-powered: 510(k) Number: K050933: Device Name: FUGO BLADE FOR PERIPHERAL ...Types of FDA 510 (k) Premarket Notification. The 510k submission process. 510k Application Timeline. Sundeep Agarwal, medical device regulatory consultant on Kolabtree, …510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... New Search: Back To Search Results: Device Classification Name: polymer patient examination glove: 510(k) Number: K223214: Device Name: Powder-Free Nitrile Examination Gloves: Applicant: Global …Sep 12, 2023 ... FDA webinar on recommendations on how companies should document their cybersecurity approach to managing risk medical devices in their ...510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... New Search: Back To Search Results: Device Classification Name: neurological stereotaxic instrument: 510(k) Number: K182417: Device Name: ROSA ONE Brain Application: Applicant: MEDTECH S.A. ZAC …510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... New Search: Back To Search Results: Device Classification Name: high flow/high velocity humidified oxygen delivery device: 510(k) Number: K221338: Device Name: F&P Airvo 3: Applicant: Fisher & …6 days ago · Date Received: 02/07/2022: Decision Date: 05/25/2022: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular Under section 524B(a) of the FD&C Act (21 U.S.C. 360n-2(a)), a person who submits a 510(k), premarket approval application (PMA), product …22. 510 (k) Number. K200983. Device Name. Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine. Applicant. Ningbo Hesi Electric Co., Ltd. No.818-23-156 Qiming Rd, Yinzhou, Ningbo City Zhejiistrict, Ningbo, Zhejiang,Device Classification Name. transcranial magnetic stimulation system for obsessive-compulsive disorder. 22. 510 (k) Number. K212289. Device Name. NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, …Date Received: 06/22/2022: Decision Date: 03/18/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Dental 510k Review Panel510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... TPLC : New Search: Back To Search Results: Device Classification Name: implant, eye valve: 510(k) Number: K220032: Device Name: iStent infinite Trabecular Micro-Bypass System, Model iS3: Applicant: …Device Classification Name: apparatus, cutting, radiofrequency, electrosurgical, battery-powered: 510(k) Number: K050933: Device Name: FUGO BLADE FOR PERIPHERAL ... Clearly provide an e-mail address for the 510(k) point of contact. You may notify the lead reviewer of your 510(k) via email of any changes to the contact information before a final decision is ... Date Received: 06/19/2017: Decision Date: 11/16/2017: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel These fees apply to Premarket Notifications (510(k)s), Premarket Approval Applications (PMAs), Product Development Protocols (PDPs), Premarket Reports (PMRs), Panel-Track Supplements, Efficacy ... Premarket Notification 510 (k) Statement. Exempt Device Review Form (PDF - 16KB) 510 (k) Cover Sheet Memorandum (PDF - 41KB) 510 (k) "Substantial …22. 510 (k) Number. K173352. Device Name. Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) Applicant. Concentric Medical, Inc. 301 East Evelyn Avenue. Mountain View, CA 94041.510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... New Search: Back To Search Results: Device Classification Name: neurological stereotaxic instrument: 510(k) Number: K182417: Device Name: ROSA ONE Brain Application: Applicant: MEDTECH S.A. ZAC …510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... TPLC : New Search: Back To Search Results: Device Classification Name: respiratory specimen nucleic acid sars-cov-2 test: 510(k) Number: K211079: Device Name: BioFire COVID-19 Test 2: Applicant: …510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... TPLC : New Search: Back To Search Results: Device Classification Name: system, imaging, pulsed doppler, ultrasonic: 510(k) Number: K231190: Device Name: EPIQ Series Diagnostic Ultrasound System: …Device Classification Name: system, image processing, radiological: 510(k) Number: K211257: Device Name: EFAI PACS Picture Archiving and Communication System In this section: Premarket Notification 510(k) Premarket Notification 510(k) 510(k) Submission Process; 510(k) Forms; 510(k) Submission Programs; How To Prepare A Special 510(k) How to Find and ... Are you tired of constantly receiving notifications that your iCloud storage is almost full? Do you find it difficult to locate and manage your files within your iCloud account? If...Are you looking to change your Aadhar card phone number? Updating your contact information is crucial to ensure that you receive important notifications and updates from the govern...Date Received: 05/13/2019: Decision Date: 07/12/2019: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel In this section: Premarket Notification 510(k) Premarket Notification 510(k) 510(k) Submission Process; 510(k) Forms; 510(k) Submission Programs; How To Prepare A Special 510(k) How to Find and ... There are three types of Premarket Notification 510(k)s that may be submitted to the FDA: Traditional, Special, and Abbreviated. In 1998, the FDA developed both the Special and Abbreviated 510(k ... Mar 4, 2024 · 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA Are you in search of a reliable source for job notifications and exam results? Look no further than Sarkariresult.com. This website has become a go-to platform for individuals seek...Date Received: 03/31/2015: Decision Date: 09/03/2015: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Gastroenterology/UrologyMar 4, 2024 · 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA Feb 22, 2021 ... What are the various routes to US FDA device clearance / approval? The majority of medical devices are cleared for marketing in the U.S. by ...Date Received: 05/20/2022: Decision Date: 02/10/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Obstetrics/Gynecology 510k Review PanelThere are 175,223,510 different possible combinations for the Powerball lottery game. Powerball is played by drawing five white balls numbered 1 to 59 from a drum and one red ball ...510 (k) Number. K221895. Device Name. Terumo Advanced Perfusion System 1. Applicant. Terumo Cardiovascular Systems Corporation. 6200 Jackson Road. Ann Arbor, MI 48103. Applicant Contact.6 days ago · Device Classification Name: self-fitting air-conduction hearing aid, over the counter: 510(k) Number: K221064: Device Name: Nuheara IQbuds 2 PRO Hearing Aid Date Received: 07/16/2021: Decision Date: 09/16/2022: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: General Hospital 510 (k) Number. K231918. Device Name. Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter. Applicant.510 (k) Submission Process. Send Medical Device eSTAR and eCopy Premarket Submissions Online. October 3, 2022 - The FDA is announcing that …Apr 22, 2023 ... Find out what should you choose for your medical device CE marking or US FDA 510(k) for approval of your medical device internationally.Feb 22, 2021 ... What are the various routes to US FDA device clearance / approval? The majority of medical devices are cleared for marketing in the U.S. by ...510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... New Search: Back To Search Results: Device Classification Name: respiratory specimen nucleic acid sars-cov-2 test: 510(k) Number: K212147: Device Name: Simplexa COVID-19 Direct: Applicant: DiaSorin …If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. …510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... TPLC : New Search: Back To Search Results: Device Classification Name: adjunctive heart failure status indicator: 510(k) Number: K222463: Device Name: EchoGo Heart Failure: Applicant: Ultromics Limited: …22. 510 (k) Number. K223591. Device Name. cobas® SARS-CoV-2 & Influenza A/B for use on the cobas® Liat System. Applicant. Roche Molecular Systems, Inc. 4300 Hacienda Drive. Pleasanton, CA 94588 -2722.Device Classification Name. transcranial magnetic stimulation system for obsessive-compulsive disorder. 22. 510 (k) Number. K212289. Device Name. NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, …510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... New Search: Back To Search Results: Device Classification Name: neurological stereotaxic instrument: 510(k) Number: K182417: Device Name: ROSA ONE Brain Application: Applicant: MEDTECH S.A. ZAC …10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDADate Received: 05/20/2022: Decision Date: 02/10/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Obstetrics/Gynecology 510k Review Panel The openFDA Device 510(k) Clearances API contains details about specific products and the original sponsors of premarket notification applications. It also contains administrative and tracking information about the applications and receipt and decision dates. For additional information, please visit the FDA's Premarket Notification 510(k) page. Oct 3, 2022 · 510 (k) Submission Process. Send Medical Device eSTAR and eCopy Premarket Submissions Online. October 3, 2022 - The FDA is announcing that you may now send electronic copy (eCopy) or... 510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... New Search: Back To Search Results: Device Classification Name: set, administration, intravascular: 510(k) Number: K222780: Device Name: LILY Extension Tube and Needleless Connector: Applicant: LILY Medical ...GE Hangwei Medical Systems Co., Ltd. West Area of Building No.3, No.1 Yongchang North Road: Beijing Economic & Technological Develop, CN 100176510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... New Search: Back To Search Results: Device Classification Name: polymer patient examination glove: 510(k) Number: K223214: Device Name: Powder-Free Nitrile Examination Gloves: Applicant: Global … Date Received: 08/17/2020: Decision Date: 12/10/2020: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Neurology Mar 28, 2022 ... Today Rob Packard recorded an updated version of the 2015 webinar about predicate selection. This is one of webinars that comprise Medical ...510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... Device Classification Name: radiological computer-assisted prioritization software for lesions: 510(k) Number: K220080: Device Name: CogNet QmTRIAGE: Applicant: MedCognetics, Inc. 17217 Waterview Parkway: …510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... New Search: Back To Search Results: Device Classification Name: implant, endosseous, root-form: 510(k) Number: K230242: Device Name: OsteoCentric Dental Implant System: Applicant: OsteoCentric …This document supersedes FDA’s Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3, dated June 30, 1986. For questions for the Center for Devices and Radiological ... photoplethysmograph analysis software for over-the-counter use. 22. 510 (k) Number. K213971. Device Name. Atrial Fibrillation History Feature. Applicant. Apple Inc. 1 Apple Park Way. 510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... TPLC : New Search: Back To Search Results: Device Classification Name: system, imaging, pulsed doppler, ultrasonic: 510(k) Number: K231966: Device Name: LOGIQ E10: Applicant: GE Medical Systems …510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... TPLC : New Search: Back To Search Results: Device Classification Name: system, imaging, pulsed doppler, ultrasonic: 510(k) Number: K231190: Device Name: EPIQ Series Diagnostic Ultrasound System: …This document supersedes FDA’s Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3, dated June 30, 1986. For questions for the Center for Devices and Radiological ...Device Classification Name: apparatus, cutting, radiofrequency, electrosurgical, battery-powered: 510(k) Number: K050933: Device Name: FUGO BLADE FOR PERIPHERAL ...510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... Back To Search Results: Device Classification Name: microbial nucleic acid storage and stabilization device: 510(k) Number: K202641: Device Name: DNA/RNA Shield Collection Tube: Applicant: Zymo …510 (k) Number. K221895. Device Name. Terumo Advanced Perfusion System 1. Applicant. Terumo Cardiovascular Systems Corporation. 6200 Jackson Road. Ann Arbor, MI 48103. Applicant Contact..