Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps— 510(k) K182773

Substantially Equivalent

Faulhaber Pinzetten Ohg

FDA 510(k) clearance K182773 for Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps, Substantially Equivalent on 2019-10-08. Applicant: Faulhaber Pinzetten Ohg.

Clearance details

Applicant
Faulhaber Pinzetten Ohg
Product code
Code GEI
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Frittlingen, DE
Download summary PDFView 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, through . 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.