IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)— 510(k) K102325

Substantially Equivalent

Covidien, LLC, Formerly Registered AS Tyco Healthca

FDA 510(k) clearance K102325 for IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD), Substantially Equivalent on 2010-10-13. Applicant: Covidien, LLC, Formerly Registered AS Tyco Healthca.

Clearance details

Applicant: Covidien, LLC, Formerly Registered AS Tyco Healthca
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2010-08-17
Decision date: 2010-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Haven, CT, US

Download summary PDF View on FDA.gov ↗

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.