FDA 510(k)

DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS

K-Number: K120258 · 2012-02-29

ApplicantCovidien, Formerly US Surgical A Divison of Tyco H

Decision Date2012-02-29

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS 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 2012-02-29 under 510(k) number K120258. 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 DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS?

DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS is a medical device that received FDA 510(k) clearance on 2012-02-29. The listed applicant is Covidien, Formerly US Surgical A Divison of Tyco H. The 510(k) number is K120258.

When did DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS receive FDA 510(k) clearance?

DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS received FDA 510(k) clearance on 2012-02-29, under 510(k) number K120258.

Who is the listed applicant for DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS?

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 DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS?

The FDA product code for DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS is GDW.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.