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FDA 510(k)

ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY

K-Number: K103263 · 2010-11-22

ApplicantCovidien, Formerly US Surgical A Divison of Tyco H
Decision Date2010-11-22
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, Formerly US Surgical A Divison of Tyco H. It received FDA 510(k) clearance on 2010-11-22 under 510(k) number K103263. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY?

ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY is a medical device that received FDA 510(k) clearance on 2010-11-22. The listed applicant is Covidien, Formerly US Surgical A Divison of Tyco H. The 510(k) number is K103263.

When did ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY receive FDA 510(k) clearance?

ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY received FDA 510(k) clearance on 2010-11-22, under 510(k) number K103263.

Who is the listed applicant for ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY?

The FDA 510(k) record lists Covidien, Formerly US Surgical A Divison of Tyco H as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY?

The FDA product code for ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY is GDW.

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Official Source

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