Clearance Summary
URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 received FDA 510(k) clearance under submission number K061333, sponsored by Uroplasty, 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 2006-07-03.
- Submission: K061333
- Applicant / Sponsor: Uroplasty, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5310
- Decision date: 2006-07-03
Classification & Regulation
This clearance is catalogued under FDA product code NAM and 21 CFR 876.5310, within the Gastroenterology, Urology review panel as a Class II device.