Skip to contentDe Novo DEN000002
- Device
- UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE
- Contact
- steven j preiss
- De Novo number
- DEN000002
- Product code
- NAM
- Regulation
- 876.5310
- Classification name
- stimulator, peripheral nerve, non-implanted, for urinary incontinence
- Decision
- granted (DENG)
- Decision date
- 2000-02-09
- Date received
- 2000-01-27
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- NAM
- Device name
- Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.5310
- Implant
- N
- Life sustain/support
- N