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FDA 510(k)

OVERSTITCH ENDOSCOPIC SUTURE SYSTEM

K-Number: K081853 · 2008-08-18

ApplicantApollo Endosurgery, Inc.
Decision Date2008-08-18
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OVERSTITCH ENDOSCOPIC SUTURE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Apollo Endosurgery, Inc.. It received FDA 510(k) clearance on 2008-08-18 under 510(k) number K081853. 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 SUTURE SYSTEM?

OVERSTITCH ENDOSCOPIC SUTURE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-08-18. The listed applicant is Apollo Endosurgery, Inc.. The 510(k) number is K081853.

When did OVERSTITCH ENDOSCOPIC SUTURE SYSTEM receive FDA 510(k) clearance?

OVERSTITCH ENDOSCOPIC SUTURE SYSTEM received FDA 510(k) clearance on 2008-08-18, under 510(k) number K081853.

Who is the listed applicant for OVERSTITCH ENDOSCOPIC SUTURE SYSTEM?

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

What is the FDA product code for OVERSTITCH ENDOSCOPIC SUTURE SYSTEM?

The FDA product code for OVERSTITCH ENDOSCOPIC SUTURE SYSTEM is OCW.

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Other records listing Apollo Endosurgery, Inc. 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 SystemK171886OverStitch SX Endoscopic Suturing System (ESS)K122270OVERTUBE ENDOSCOPIC ACCESS SYSTEM

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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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