Resection Electrodes— 510(k) K152092

Substantially Equivalent

Olympus Winter & Ibe GmbH

FDA 510(k) clearance K152092 for Resection Electrodes, Substantially Equivalent on 2015-10-26. Applicant: Olympus Winter & Ibe GmbH.

Clearance details

Applicant: Olympus Winter & Ibe GmbH
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 2015-07-28
Decision date: 2015-10-26
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.