Clearance Summary
SEGURA BASKET received FDA 510(k) clearance under submission number K841942, 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 1984-07-19.
- Submission: K841942
- Applicant / Sponsor: Van-Tec, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4680
- Decision date: 1984-07-19
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.