De Novo DEN230061
- Device
- allay Nerve Cap
- Contact
- corinne bright
- De Novo number
- DEN230061
- Product code
- SBG
- Regulation
- 882.5260
- Classification name
- in situ polymerizing peripheral nerve cap
- Decision
- granted (DENG)
- Decision date
- 2024-07-16
- Date received
- 2023-09-12
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- SBG
- Device name
- In Situ Polymerizing Peripheral Nerve Cap
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.5260
- Implant
- Y
- Life sustain/support
- N