Clearance Summary
URETERAL DILATION SET received FDA 510(k) clearance under submission number K851144, sponsored by Van-Tec, 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 1985-04-09.
- Submission: K851144
- Applicant / Sponsor: Van-Tec, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5470
- Decision date: 1985-04-09
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.