Resection Electrodes with HF cable— 510(k) K210651

Substantially Equivalent

Olympus Winter & Ibe GmbH

FDA 510(k) clearance K210651 for Resection Electrodes with HF cable, Substantially Equivalent on 2021-08-03. Applicant: Olympus Winter & Ibe GmbH.

Clearance details

Applicant: Olympus Winter & Ibe GmbH
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 2021-03-04
Decision date: 2021-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamburg, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAS

product code FAS

Death: 3
Injury: 344
Malfunction: 1,130
Total: 1,477

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.