Skip to contentDe Novo DEN210052
- Device
- Vibrant System
- Contact
- lior ben tsur
- De Novo number
- DEN210052
- Product code
- QTN
- Regulation
- 876.5940
- Classification name
- orally ingested transient device for constipation
- Decision
- granted (DENG)
- Decision date
- 2022-08-26
- Date received
- 2021-11-30
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- QTN
- Device name
- Orally Ingested Transient Device For Constipation
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.5940
- Implant
- N
- Life sustain/support
- N