RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS— 510(k) K102781

Substantially Equivalent

Olympus Winter & Ibe GmbH

FDA 510(k) clearance K102781 for RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS, Substantially Equivalent on 2011-01-11. Applicant: Olympus Winter & Ibe GmbH.

Clearance details

Applicant: Olympus Winter & Ibe GmbH
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 2010-09-27
Decision date: 2011-01-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Center Valley, PA, US

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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.