510(k) K252051
- Device
- allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)
- Applicant
- Tulavi Therapeutics, Inc.
- 510(k) number
- K252051
- Product code
- SBG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-09-29
- Date received
- 2025-07-01
- Regulation
- 882.5260
- Classification name
- In Situ Polymerizing Peripheral Nerve Cap
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Joshua G. Vose
- Address
- 160 Knowles Dr. Los Gatos CA US 95032 95032
FDA Registration Numbers#
- 3027562169
Source Documents#
Other 510(k) Records For Product Code SBG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN230061 | allay Nerve Cap | Tulavi Therapeutics | 2024-07-16 |