ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES— 510(k) K102921

Substantially Equivalent

Bema-GmbH & Co. KG

FDA 510(k) clearance K102921 for ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES, Substantially Equivalent on 2011-12-20. Applicant: Bema-GmbH & Co. KG.

Clearance details

Applicant: Bema-GmbH & Co. KG
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2010-10-01
Decision date: 2011-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amsterdam, NL

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.