Clearance Summary
URETHRAL BALLOON DILATION CATHETER SET received FDA 510(k) clearance under submission number K892855, sponsored by Cook Urological, 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 1989-11-17.
- Submission: K892855
- Applicant / Sponsor: Cook Urological, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5520
- Decision date: 1989-11-17
Classification & Regulation
This clearance is catalogued under FDA product code KOE and 21 CFR 876.5520, within the Gastroenterology, Urology review panel as a Class II device.