Clearance Summary
Tri-Ex Extraction Balloon with Multiple Sizing received FDA 510(k) clearance under submission number K193344, sponsored by 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 2019-12-13.
- Submission: K193344
- Applicant / Sponsor: Wilson-Cook Medical, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 2019-12-13
Classification & Regulation
This clearance is catalogued under FDA product code GCA and 21 CFR 876.5010, within the Gastroenterology, Urology review panel as a Class II device.