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FDA 510(k)

AbClose - Port Site Closure Device

K-Number: K193652 · 2020-03-26

ApplicantMedeon Biodesign, Inc.
Decision Date2020-03-26
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AbClose - Port Site Closure Device is a medical device manufactured by Medeon Biodesign, Inc.. It received FDA 510(k) clearance on 2020-03-26 under approval number K193652. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AbClose - Port Site Closure Device?

AbClose - Port Site Closure Device is a medical device that received FDA 510(k) clearance on 2020-03-26. It is manufactured by Medeon Biodesign, Inc.. The 510(k) number is K193652.

When was AbClose - Port Site Closure Device approved by the FDA?

AbClose - Port Site Closure Device received FDA 510(k) clearance on 2020-03-26, under approval number K193652.

What company makes AbClose - Port Site Closure Device?

AbClose - Port Site Closure Device is manufactured by Medeon Biodesign, Inc..

What is the FDA product code for AbClose - Port Site Closure Device?

The FDA product code for AbClose - Port Site Closure Device is OCW.

Related Clinical Trials

NCT07262255 WATCHMAN FLX Pro European Registry RECRUITING NCT05147792 The CONFORM Pivotal Trial RECRUITING NCT05069558 Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion ACTIVE_NOT_RECRUITING NCT05744934 Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study COMPLETED NCT04394546 CHAMPION-AF Clinical Trial ACTIVE_NOT_RECRUITING NCT06686485 cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia RECRUITING

Related PubMed Literature

PMID: 38822140 "The novel dura substitute: a revolutionary advancement in neurosurgery". Neurosurgical review (2024) PMID: 38569929 Utilization of Bone-Anchored Annular Defect Closure to Prevent Reherniation Following Lumbar Discectomy: Overcoming Barriers to Clinical Adoption and Market Access. International journal of spine surgery (2024) PMID: 28988455 Safety profiles of percutaneous left atrial appendage closure devices: An analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database from 2009 to 2016. Journal of cardiovascular electrophysiology (2018) PMID: 25938303 Safety and Procedural Success of Left Atrial Appendage Exclusion With the Lariat Device: A Systematic Review of Published Reports and Analytic Review of the FDA MAUDE Database. JAMA internal medicine (2015)

Other Devices by Medeon Biodesign, Inc.

K160117AbClose - Port Site Closure Device K160172Laparoscope Lens Shield Device K170103Laparoscope Lens Shield Device (LENS) K192891Laparoscope Lens Shield Device (LENS) K200902ClickClean

Related Devices (Code: OCW)

K160117AbClose - Port Site Closure DeviceMedeon Biodesign, Inc. K160149Miret Grasper, Alligator, Miret Grasper, MarylandMiret Surgical, Inc. K172666CrossBow Fascial Closure System, CrossBow Fascial Closure System with AdaptorSutureease, Inc. K171886OverStitch SX Endoscopic Suturing System (ESS)Apollo Endosurgery, Inc. K181141OverStitch Endoscopic Suturing System and AccessoriesApollo Endosurgery K172775MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleTeleflexmedical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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