510(k) DEN230061
DEN230061 is an FDA 510(k) premarket notification submitted by Tulavi Therapeutics for the device "allay Nerve Cap". The FDA issued a decision of De Novo Granted on July 16, 2024. The device falls under product code SBG (In Situ Polymerizing Peripheral Nerve Cap), a Class II device regulated under 21 CFR 882.5260. Tulavi Therapeutics has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 16, 2024
- Date Received
- September 12, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- In Situ Polymerizing Peripheral Nerve Cap
- Device Class
- Class II
- Regulation Number
- 882.5260
- Review Panel
- NE
- Submission Type
An in situ polymerizing peripheral nerve cap is a prescription use only device composed of precursor materials that polymerize when delivered to the end of a peripheral nerve to function as a physical barrier to the surrounding in vivo environment to reduce the risk of formation of a symptomatic neuroma.