Clearance Summary
WILSON-COOK BALLOON INFLATION DEVICE received FDA 510(k) clearance under submission number K933845, 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 1994-11-29.
- Submission: K933845
- Applicant / Sponsor: Wilson-Cook Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5365
- Decision date: 1994-11-29
Classification & Regulation
This clearance is catalogued under FDA product code KNQ and 21 CFR 876.5365, within the Gastroenterology, Urology review panel as a Class II device.