De Novo DEN220052
- Device
- BrachyGel Vaginal Hydrogel Packing System
- Contact
- timothy showalter, md, mph
- De Novo number
- DEN220052
- Product code
- QXR
- Regulation
- 892.5735
- Classification name
- vaginal hydrogel packing system
- Decision
- granted (DENG)
- Decision date
- 2023-08-22
- Date received
- 2022-08-25
- Classification advisory
- Radiology
- Review advisory
- Radiology
- Type
- Direct
Current FDA Classification#
- Product code
- QXR
- Device name
- Vaginal Hydrogel Packing System
- Medical specialty
- Radiology
- Device class
- 2
- Regulation
- 892.5735
- Implant
- N
- Life sustain/support
- N