IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER— 510(k) K121510

Name: FDA 510(k) clearance K121510
Creator: U.S. Food and Drug Administration
Published: 2012-07-25

Substantially Equivalent

Covidien, Formerly US Surgical A Divison of Tyco H

FDA 510(k) clearance K121510 for IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER, Substantially Equivalent on 2012-07-25. Applicant: Covidien, Formerly US Surgical A Divison of Tyco H. Device class: 2.

Clearance details

Applicant: Covidien, Formerly US Surgical A Divison of Tyco H
Product code: Code GDW
Device class: Class 2
Regulation: 21 CFR 878.4750
Advisory panel: General, Plastic Surgery
Date received: 2012-05-21
Decision date: 2012-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Haven, CT, US

Download summary PDF View on FDA.gov ↗

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More clearances from Covidien, Formerly US Surgical A Divison of Tyco H

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K131705 — ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY2013-07-01
K130532 — IDRIVE ULTRA STERILIZATION TRAY2013-05-30
K130717 — ENDO GIA RELOAD2013-04-18
K130435 — VERSAPORT V2 BLADELESS OPTICAL TROCAR2013-03-14
K122781 — RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD2013-02-05

Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.