Clearance Summary
Fusion OMNI Sphincterotome received FDA 510(k) clearance under submission number K172288, sponsored by Wilson-Cook Medical Inc./Cook Endoscopy. 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 2018-04-17.
- Submission: K172288
- Applicant / Sponsor: Wilson-Cook Medical Inc./Cook Endoscopy
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 2018-04-17
Classification & Regulation
This clearance is catalogued under FDA product code KNS and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.