Clearance Summary
Balloon Catheter and Balloon Ureteral Dilator Set received FDA 510(k) clearance under submission number K172588, sponsored by Cook Incorporated. 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 2018-04-19.
- Submission: K172588
- Applicant / Sponsor: Cook Incorporated
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5470
- Decision date: 2018-04-19
Classification & Regulation
This clearance is catalogued under FDA product code EZN and 21 CFR 876.5470, within the Gastroenterology, Urology review panel as a Class II device.