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FDA 510(k)

OverStitch Endoscopic Suturing System and Accessories

K-Number: K181141 · 2018-06-27

ApplicantApollo Endosurgery
Decision Date2018-06-27
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OverStitch Endoscopic Suturing System and Accessories is a medical device manufactured by Apollo Endosurgery. It received FDA 510(k) clearance on 2018-06-27 under approval number K181141. 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 Endoscopic Suturing System and Accessories?

OverStitch Endoscopic Suturing System and Accessories is a medical device that received FDA 510(k) clearance on 2018-06-27. It is manufactured by Apollo Endosurgery. The 510(k) number is K181141.

When was OverStitch Endoscopic Suturing System and Accessories approved by the FDA?

OverStitch Endoscopic Suturing System and Accessories received FDA 510(k) clearance on 2018-06-27, under approval number K181141.

What company makes OverStitch Endoscopic Suturing System and Accessories?

OverStitch Endoscopic Suturing System and Accessories is manufactured by Apollo Endosurgery.

What is the FDA product code for OverStitch Endoscopic Suturing System and Accessories?

The FDA product code for OverStitch Endoscopic Suturing System and Accessories is OCW.

Related Clinical Trials

NCT07276815 OverStitch NXT Endoscopic Suture System NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07581977 A Novel Two-Tooth Clip for ESD and EFTR of GIST RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT07574918 Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis NOT_YET_RECRUITING NCT03714412 Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System WITHDRAWN

Other Devices by Apollo Endosurgery

K191439OverStitch 2-0 Polypropylene Suture

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. K172775MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleTeleflexmedical, Inc. K191439OverStitch 2-0 Polypropylene SutureApollo Endosurgery

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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