WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS— 510(k) K100275
Substantially EquivalentOlympus Winter & Ibe GmbH
FDA 510(k) clearance K100275 for WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS, Substantially Equivalent on 2010-07-01. Applicant: Olympus Winter & Ibe GmbH.
Clearance details
- Applicant
- Olympus Winter & Ibe GmbH
- Product code
- Code FAS
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Center Valley, PA, US
Adverse events under product code FAS
product code FAS- Death
- 3
- Injury
- 344
- Malfunction
- 1,130
- Total
- 1,477
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.