Clearance Summary
VISION SYSTEM UPPER G.I. EXDOSCOPE received FDA 510(k) clearance under submission number K943715, sponsored by Vision-Sciences, 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 1995-02-24.
- Submission: K943715
- Applicant / Sponsor: Vision-Sciences, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1995-02-24
Classification & Regulation
This clearance is catalogued under FDA product code FDS and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.