Clearance Summary
ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES received FDA 510(k) clearance under submission number K120418, sponsored by Olympus Winter & Ibe GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2012-06-20.
- Submission: K120418
- Applicant / Sponsor: Olympus Winter & Ibe GmbH
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 2012-06-20
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.