# DEN230061: allay Nerve Cap

- Pathway: De Novo (Direct)
- Applicant: Tulavi Therapeutics
- Decided: Jul 16, 2024 after 308 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K252051: allay Nerve Cap  (TL5515-1); allay Nerve Cap  (TL5515-2); Delivery Tips (TL-7627) (2025), 0 descendants of its own

## Indications for use
The allay Nerve Cap is indicated for use in adults aged 22 years or older 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/DEN230061
Methodology: https://510kreport.com/methodology