Clearance Summary
MULTI-BITE HOT BIOPSY FORCEPS received FDA 510(k) clearance under submission number K090796, sponsored by Endo-Therapeutics, 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 2009-11-25.
- Submission: K090796
- Applicant / Sponsor: Endo-Therapeutics, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 2009-11-25
Classification & Regulation
This clearance is catalogued under FDA product code KGE and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.