Clearance Summary
COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K received FDA 510(k) clearance under submission number K111495, 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 2011-07-19.
- Submission: K111495
- Applicant / Sponsor: Wilson-Cook Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2011-07-19
Classification & Regulation
This clearance is catalogued under FDA product code FBK and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.