Clearance Summary
MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR received FDA 510(k) clearance under submission number K020526, sponsored by Don Wilson/Wilson-Cook Medical, Inc.. 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 2002-03-19.
- Submission: K020526
- Applicant / Sponsor: Don Wilson/Wilson-Cook Medical, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4400
- Decision date: 2002-03-19
Classification & Regulation
This clearance is catalogued under FDA product code FHN and 21 CFR 876.4400, within the Gastroenterology, Urology review panel as a Class II device.