Clearance Summary
ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 received FDA 510(k) clearance under submission number K031262, sponsored by Ndo Surgical, 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 2003-05-23.
- Submission: K031262
- Applicant / Sponsor: Ndo Surgical, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2003-05-23
Classification & Regulation
This clearance is catalogued under FDA product code ODE and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.