Clearance Summary
MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE received FDA 510(k) clearance under submission number K053560, sponsored by Vision-Sciences, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2006-03-16.
- Submission: K053560
- Applicant / Sponsor: Vision-Sciences, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2006-03-16
Classification & Regulation
This clearance is catalogued under FDA product code FAJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.