Clearance Summary
NURO NEUROMODULATION SYSTEM received FDA 510(k) clearance under submission number K132561, sponsored by Advanced Uro-Solutions, 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 2013-11-05.
- Submission: K132561
- Applicant / Sponsor: Advanced Uro-Solutions, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5310
- Decision date: 2013-11-05
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.