Clearance Summary
VAN-TEC POSITIVE OPEN SEGURA BASKET received FDA 510(k) clearance under submission number K870615, 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 1987-03-25.
- Submission: K870615
- Applicant / Sponsor: Van-Tec, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4680
- Decision date: 1987-03-25
Classification & Regulation
This clearance is catalogued under FDA product code FFL and 21 CFR 876.4680, within the Gastroenterology, Urology review panel as a Class II device.