Clearance Summary
WILSON-COOK REUSABLE HOT BIOPSY FORCEPS received FDA 510(k) clearance under submission number K000086, sponsored by Wilson-Cook Medical, Inc.. 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 2000-03-15.
- Submission: K000086
- Applicant / Sponsor: Wilson-Cook Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 2000-03-15
Classification & Regulation
This clearance is catalogued under FDA product code KGE and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.