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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 the device name listed in this FDA 510(k) record. The listed applicant is Apollo Endosurgery. It received FDA 510(k) clearance on 2019-08-29 under 510(k) 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. The listed applicant is Apollo Endosurgery. The 510(k) number is K191439.

When did OverStitch 2-0 Polypropylene Suture receive FDA 510(k) clearance?

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

Who is the listed applicant for OverStitch 2-0 Polypropylene Suture?

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 2-0 Polypropylene Suture?

The FDA product code for OverStitch 2-0 Polypropylene Suture 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 SystemK181141OverStitch Endoscopic Suturing System and AccessoriesK171886OverStitch 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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