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510(k) K252051

allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) by Tulavi Therapeutics, Inc. — Product Code SBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2025
Date Received
July 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.

Other clearances by Tulavi Therapeutics, Inc.

  • DEN230061 — allay Nerve Cap (July 16, 2024)

Other clearances for product code SBG

  • DEN230061 — allay Nerve Cap (July 16, 2024)