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Idrive Ultra Powered Handle Endo Gia Adapter

by Covidien, Formerly US Surgical A Divison of Tyco H

510(k) K121510

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 NumberK121510 Date25 Jul 2012ClearedStatusActive

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  • Withdrawn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, 22 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 powered handle adapter designed for use with Endo GIA™ single-use reloads in surgical procedures. It functions as a component of a stapling system used for resection, transection, and creation of anastomosis.

It is intended for use in abdominal, gynecological, pediatric, and thoracic surgery settings. The device is supplied as a reusable handle adapter that requires single-use reloads for operation. Authorization is based on FDA 510(k) clearance under K121510, with device classification as a staple, implantable.

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Questions

AI-generated answers, 22 Sep 2026

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

  • What is the IDRIVE ULTRA Powered Handle Endo GIA Adapter used for?

    It is a powered handle adapter designed to work with Endo GIA™ single-use reloads in surgical procedures, functioning as part of a stapling system for resection, transection, and creation of anastomosis in abdominal, gynecological, pediatric, and thoracic surgery settings.

  • Is the IDRIVE ULTRA Powered Handle Endo GIA Adapter reusable or single-use?

    The device is supplied as a reusable handle adapter, but it requires single-use Endo GIA™ reloads for operation, meaning the handle itself can be reused while the reloads are discarded after each use.

  • What regulatory pathway was used for the IDRIVE ULTRA Powered Handle Endo GIA Adapter?

    Authorization is based on FDA 510(k) clearance under K121510, with the device classified as a staple, implantable under product code GDW and regulation number 878.4750.