# DEN240066: COAPTIUM Connect with TISSIUM LIGHT

- Pathway: De Novo (Direct)
- Applicant: Tissium SA
- Decided: Jun 17, 2025 after 208 days
- Product code: SFD (In Situ Polymerizing Peripheral Nerve Repair Device)
- Device class: 2
- Regulation: 21 CFR 882.5270
- 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
- K251957: Coaptium Connect with Tissium Light (2025), 0 descendants of its own

## Indications for use
COAPTIUM CONNECT with TISSIUM LIGHT is indicated for the sutureless repair of peripheral nerve injuries not in continuity in which a gap closure ≤ 1 cm is present or can be achieved with flexion of the extremity.

Source page: https://510kreport.com/device/DEN240066
Methodology: https://510kreport.com/methodology