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
Source Documents
510(k) summary PDF not indicated by FDA
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 10860012518125 | Delivery Tip | Tulavi Therapeutics, Inc. | 2024-09-20 |
| 00860012518111 | allay™ Nerve Cap - Large Nerve Set | Tulavi Therapeutics, Inc. | 2024-08-05 |
| 00860012518104 | allay™ Nerve Cap - Small Nerve Set | Tulavi Therapeutics, Inc. | 2024-08-05 |
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 |