Clearance Summary
WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS received FDA 510(k) clearance under submission number K100275, sponsored by Olympus Winter & Ibe GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2010-07-01.
- Submission: K100275
- Applicant / Sponsor: Olympus Winter & Ibe GmbH
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 2010-07-01
Classification & Regulation
This clearance is catalogued under FDA product code FAS and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.