Clearance Summary
COLONOSCOPE/SIGMOIDOSCOPE SHEATHES received FDA 510(k) clearance under submission number K100966, sponsored by Sheathing Technologies, 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 2010-08-03.
- Submission: K100966
- Applicant / Sponsor: Sheathing Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2010-08-03
Classification & Regulation
This clearance is catalogued under FDA product code FDF and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.