ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES— 510(k) K120418

Substantially Equivalent

Olympus Winter & Ibe GmbH

FDA 510(k) clearance K120418 for ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES, Substantially Equivalent on 2012-06-20. Applicant: Olympus Winter & Ibe GmbH.

Clearance details

Applicant: Olympus Winter & Ibe GmbH
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 2012-02-10
Decision date: 2012-06-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Center Valley, PA, US

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.