allay Nerve Cap
FDA 510(k) clearance DEN230061 · decided 2024-07-16
Clearance details
- K-number
- DEN230061
- Device name
- allay Nerve Cap
- Applicant
- Tulavi Therapeutics
- Decision
- Unknown
- Date received
- 2023-09-12
- Decision date
- 2024-07-16
- Days to decision
- 308 days
- Clearance type
- Direct
- Product code
- SBG
- Device class
- 2
- Regulation number
- 882.5260
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Lost Gatos, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) (K252051) | Tulavi Therapeutics, Inc. | 2025-09-29 |
Recalls involving this device
No recalls on record reference this clearance.