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FDA 510(k)

OverStitch NXT Endoscopic Suturing System

K-Number: K231553 · 2023-06-29

ApplicantApollo Endosurgery, Inc.
Decision Date2023-06-29
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OverStitch NXT Endoscopic Suturing System is a medical device manufactured by Apollo Endosurgery, Inc.. It received FDA 510(k) clearance on 2023-06-29 under approval number K231553. 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 NXT Endoscopic Suturing System?

OverStitch NXT Endoscopic Suturing System is a medical device that received FDA 510(k) clearance on 2023-06-29. It is manufactured by Apollo Endosurgery, Inc.. The 510(k) number is K231553.

When was OverStitch NXT Endoscopic Suturing System approved by the FDA?

OverStitch NXT Endoscopic Suturing System received FDA 510(k) clearance on 2023-06-29, under approval number K231553.

What company makes OverStitch NXT Endoscopic Suturing System?

OverStitch NXT Endoscopic Suturing System is manufactured by Apollo Endosurgery, Inc..

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

The FDA product code for OverStitch NXT Endoscopic Suturing System 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 NCT07568366 AI in Endoscopic Transsphenoidal Surgery NOT_YET_RECRUITING

Other Devices by Apollo Endosurgery, Inc.

K171886OverStitch SX Endoscopic Suturing System (ESS) K201808X-Tack Endoscopic HeliX Tacking System K210266OverStitch Sx Endoscopic Suturing System DEN210045APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System K232544Apollo ESG NXT System, Apollo REVISE NXT System

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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