Clearance Summary
UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE received FDA 510(k) clearance under submission number DEN000002, sponsored by Urosurge, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2000-02-09.
- Submission: DEN000002
- Applicant / Sponsor: Urosurge, Inc.
- Clearance pathway: Post-NSE
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5310
- Decision date: 2000-02-09
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.