MSD BIPOLAR FORCEPS— 510(k) K061635

Substantially Equivalent

Medtronic Sofamor Danek

FDA 510(k) clearance K061635 for MSD BIPOLAR FORCEPS, Substantially Equivalent on 2006-09-05. Applicant: Medtronic Sofamor Danek.

Clearance details

Applicant: Medtronic Sofamor Danek
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2006-06-12
Decision date: 2006-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.