FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
allay Nerve Cap
K Number: DEN230061
·
Decision Jul 16, 2024
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
1
Review Days
308
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Basic Information
- Device Name
- allay Nerve Cap
- K Number
- DEN230061
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 882.5260
- Medical Specialty
- Neurology
- Decision
- Unknown
- Applicant
- Tulavi Therapeutics
- Date Received
- September 12, 2023
- Decision Date
- July 16, 2024
- Product Code
- SBG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SBG | In Situ Polymerizing Peripheral Nerve Cap | FDA class 2 | Neurology |
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