Clearance Summary
Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter received FDA 510(k) clearance under submission number K171548, 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 2017-10-13.
- Submission: K171548
- Applicant / Sponsor: Wilson-Cook Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 2017-10-13
Classification & Regulation
This clearance is catalogued under FDA product code FGE and 21 CFR 876.5010, within the Gastroenterology, Urology review panel as a Class II device.