Signia Small Diameter Reloads Including Regular (Round) Tip Version— 510(k) K222641

Substantially Equivalent

Covidien

FDA 510(k) clearance K222641 for Signia Small Diameter Reloads Including Regular (Round) Tip Version, Substantially Equivalent on 2022-11-29. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2022-09-01
Decision date: 2022-11-29
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.