DEN230061
- 510(k) number
- DEN230061
- Device name
- allay Nerve Cap
- Applicant
- Tulavi Therapeutics CA · US
- Product code
- SBG — In Situ Polymerizing Peripheral Nerve Cap
- Decision date
- 2024-07-16
- Date received
- 2023-09-12
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Neurology
Official FDA record: DEN230061
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.