510(k) DEN000002
DEN000002 is an FDA 510(k) premarket notification submitted by Urosurge, Inc. for the device "UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE". The FDA issued a decision of De Novo Granted on February 9, 2000. The device falls under product code NAM (Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence), a Class II device regulated under 21 CFR 876.5310. Urosurge, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 9, 2000
- Date Received
- January 27, 2000
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
- Device Class
- Class II
- Regulation Number
- 876.5310
- Review Panel
- GU
- Submission Type