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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 the device name listed in this FDA 510(k) record. The listed applicant is Apollo Endosurgery. It received FDA 510(k) clearance on 2018-06-27 under 510(k) 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. The listed applicant is Apollo Endosurgery. The 510(k) number is K181141.

When did OverStitch Endoscopic Suturing System and Accessories receive FDA 510(k) clearance?

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

Who is the listed applicant for OverStitch Endoscopic Suturing System and Accessories?

The FDA 510(k) record lists Apollo Endosurgery as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Apollo Endosurgery as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232544Apollo ESG NXT System, Apollo REVISE NXT SystemK231553OverStitch NXT Endoscopic Suturing SystemK210266OverStitch Sx Endoscopic Suturing SystemK201808X-Tack Endoscopic HeliX Tacking SystemK191439OverStitch 2-0 Polypropylene SutureK171886OverStitch SX Endoscopic Suturing System (ESS)

View all 7 devices →

Related Devices (Code: OCW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252400Endomina EZFuse systemEndo Tools Therapeutics S.A.K243750SimpleStitch Suturing SystemEnvision EndoscopyK231240MaxTack™ Motorized Fixation DeviceCovidienK213271MedicloseTM SystemHealth Value Creation B.V., Trading AS Corporis MedicalK231553OverStitch NXT Endoscopic Suturing SystemApollo Endosurgery, Inc.K211309endomina systemEndo Tools Therapeutics S.A.

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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