Clearance Summary
VAN-TEC MEATAL DILATOR received FDA 510(k) clearance under submission number K851158, 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 1985-04-15.
- Submission: K851158
- Applicant / Sponsor: Van-Tec, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5520
- Decision date: 1985-04-15
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.