# K252051: allay Nerve Cap  (TL5515-1); allay Nerve Cap  (TL5515-2); Delivery Tips (TL-7627)

- Pathway: 510(k) (Traditional)
- Applicant: Tulavi Therapeutics, Inc.
- Decided: Sep 29, 2025 after 90 days
- Product code: SBG (In Situ Polymerizing Peripheral Nerve Cap)
- Device class: 2
- Regulation: 21 CFR 882.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN230061 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230061: allay Nerve Cap, Tulavi Therapeutics (2024) Summary page 5.

## Indications for use
The allay™ Nerve Cap is indicated for use in individuals weighing 25 kg or more as a physical barrier to separate the peripheral nerve end from the surrounding environment to reduce the risk of the development of a symptomatic neuroma.

Source page: https://510kreport.com/device/K252051
Methodology: https://510kreport.com/methodology