Clearance Summary
DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998 received FDA 510(k) clearance under submission number K091355, sponsored by Conmed Endoscopic 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 2009-07-22.
- Submission: K091355
- Applicant / Sponsor: Conmed Endoscopic Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 2009-07-22
Classification & Regulation
This clearance is catalogued under FDA product code FDI and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.