510(k) DEN230061
- Device
- allay Nerve Cap
- Applicant
- Tulavi Therapeutics
- 510(k) number
- DEN230061
- Product code
- SBG
- Decision
- Unknown (DENG)
- Decision date
- 2024-07-16
- Date received
- 2023-09-12
- Regulation
- 882.5260
- Classification name
- In Situ Polymerizing Peripheral Nerve Cap
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Corinne Bright
- Address
- 160 Knowles Ave. Lost Gatos CA US 95032 95032
FDA Registration Numbers#
- 3027562169
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code SBG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252051 | allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) | Tulavi Therapeutics, Inc. | 2025-09-29 |