FDA 510(k)

ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY

K-Number: K131705 · 2013-07-01

ApplicantCovidien, Formerly US Surgical A Divison of Tyco H

Decision Date2013-07-01

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ENDO GIA RADIAL RELOAD WITH TRI-STAPLE 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 2013-07-01 under 510(k) number K131705. 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 RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY?

ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY is a medical device that received FDA 510(k) clearance on 2013-07-01. The listed applicant is Covidien, Formerly US Surgical A Divison of Tyco H. The 510(k) number is K131705.

When did ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY receive FDA 510(k) clearance?

ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY received FDA 510(k) clearance on 2013-07-01, under 510(k) number K131705.

Who is the listed applicant for ENDO GIA RADIAL RELOAD WITH TRI-STAPLE 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 RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY?

The FDA product code for ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY is GDW.

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K130532IDRIVE ULTRA STERILIZATION TRAY K130717ENDO GIA RELOAD K130435VERSAPORT V2 BLADELESS OPTICAL TROCAR K122781RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD K123318IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER K121510IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER

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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.