Clearance Summary
DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE received FDA 510(k) clearance under submission number K963344, 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 1996-11-21.
- Submission: K963344
- Applicant / Sponsor: Vision-Sciences, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1996-11-21
Classification & Regulation
This clearance is catalogued under FDA product code FAM and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.