NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX— 510(k) K101080

Substantially Equivalent

Egon Faulhaber Surgical Instruments Pinzetten

FDA 510(k) clearance K101080 for NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX, Substantially Equivalent on 2010-06-21. Applicant: Egon Faulhaber Surgical Instruments Pinzetten.

Clearance details

Applicant: Egon Faulhaber Surgical Instruments Pinzetten
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2010-04-19
Decision date: 2010-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wurmlingen, DE

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.