Skip to contentDe Novo DEN230082
- Device
- Stone Clear (SC-LP9-01)
- Contact
- oren levy
- De Novo number
- DEN230082
- Product code
- QNA
- Regulation
- 876.4690
- Classification name
- ultrasonic urinary stone propulsion device
- Decision
- granted (DENG)
- Decision date
- 2024-10-30
- Date received
- 2023-12-07
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- QNA
- Device name
- Ultrasonic Urinary Stone Propulsion Device
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.4690
- Implant
- N
- Life sustain/support
- N