510(k) K252051
K252051 is an FDA 510(k) premarket notification submitted by Tulavi Therapeutics, Inc. for the device "allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)". The FDA issued a decision of Substantially Equivalent on Sep 29, 2025. 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, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 29, 2025
- Date Received
- Jul 1, 2025
- Clearance Type
- Traditional
- 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.