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Auto Suture Endoscopic (& Open) TA Surgical Stapler, Auto Suture Endoscopic (& Open) GIA Surgical Stapling Instrument

by United States Surgical, A Division of Tyco Healthc

510(k) K032696

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032696 Date1 Dec 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GDW
Device Class
Class II
Regulation
21 CFR Part 878.4750
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a surgical stapler designed to place multiple staggered rows of titanium or stainless steel staples into tissue. It is used in abdominal, gynecologic, pediatric, and thoracic procedures for resection, transection, and creation of anastomoses, including left atrial appendage occlusion.

The device is supplied as a reusable instrument and has received FDA 510(k) clearance under K number K032696. It is classified as a Class II medical device with product code GDW and regulation number 878.4750, and was determined to be substantially equivalent to a predicate device.

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