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FDA 510(k)

OverStitch 2-0 Polypropylene Suture

K-Number: K191439 · 2019-08-29

ApplicantApollo Endosurgery
Decision Date2019-08-29
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OverStitch 2-0 Polypropylene Suture is a medical device manufactured by Apollo Endosurgery. It received FDA 510(k) clearance on 2019-08-29 under approval number K191439. 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 OverStitch 2-0 Polypropylene Suture?

OverStitch 2-0 Polypropylene Suture is a medical device that received FDA 510(k) clearance on 2019-08-29. It is manufactured by Apollo Endosurgery. The 510(k) number is K191439.

When was OverStitch 2-0 Polypropylene Suture approved by the FDA?

OverStitch 2-0 Polypropylene Suture received FDA 510(k) clearance on 2019-08-29, under approval number K191439.

What company makes OverStitch 2-0 Polypropylene Suture?

OverStitch 2-0 Polypropylene Suture is manufactured by Apollo Endosurgery.

What is the FDA product code for OverStitch 2-0 Polypropylene Suture?

The FDA product code for OverStitch 2-0 Polypropylene Suture is OCW.

Related Clinical Trials

NCT07276815 OverStitch NXT Endoscopic Suture System NOT_YET_RECRUITING NCT06511414 Effect of Duramesh™ on Hernia Formation After Ileostomy Closure ACTIVE_NOT_RECRUITING

Other Devices by Apollo Endosurgery

K181141OverStitch Endoscopic Suturing System and Accessories

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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