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FDA 510(k)

MODIFIED ENDO STICH

K-Number: K082659 · 2008-09-19

ApplicantCovidien Lp, Formerly Registered AS United States
Decision Date2008-09-19
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFIED ENDO STICH is the device name listed in this FDA 510(k) record. The listed applicant is Covidien Lp, Formerly Registered AS United States. It received FDA 510(k) clearance on 2008-09-19 under 510(k) number K082659. 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 MODIFIED ENDO STICH?

MODIFIED ENDO STICH is a medical device that received FDA 510(k) clearance on 2008-09-19. The listed applicant is Covidien Lp, Formerly Registered AS United States. The 510(k) number is K082659.

When did MODIFIED ENDO STICH receive FDA 510(k) clearance?

MODIFIED ENDO STICH received FDA 510(k) clearance on 2008-09-19, under 510(k) number K082659.

Who is the listed applicant for MODIFIED ENDO STICH?

The FDA 510(k) record lists Covidien Lp, Formerly Registered AS United States as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED ENDO STICH?

The FDA product code for MODIFIED ENDO STICH is OCW.

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Other records listing Covidien Lp, Formerly Registered AS United States 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.

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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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