FDA Product Code
FDA Product Code SBG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5260
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252051 | allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) | Tulavi Therapeutics, Inc. | 2025-09-29 | Traditional | PDF ↗ |
| DEN230061 | allay Nerve Cap | Tulavi Therapeutics | 2024-07-16 | Direct | — |
Product code SBG · Class II · Neurology. Data: openFDA.