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Coaptium Connect with Tissium Light

FDA 510(k)

Class II (US FDA 510(k))

510(k) DEN240066

by Tissium SA

Identifiers

510(k) Number
DEN240066 FDA 510(k)
FDA Product Code
SFD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5270 FDA 510(k)
Regulation Number
882.5270 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
DENG FDA 510(k)

Coaptium Connect with Tissium Light is an in situ polymerizing peripheral nerve repair device designed for sutureless nerve coaptation. The system utilizes a biopolymer platform to connect nerve ends, creating a coaptation that reduces stress at the repair site.

The Tissium Light component is a reusable, non-sterile device used to photoactivate the Coaptium polymer. The Coaptium Connect components are supplied sterile for single use in double peel packages and are available in a variety of sizes. This device has received FDA 510(k) authorization.

Frequently asked questions

What is the primary function of the Coaptium Connect system?

The system is designed for sutureless peripheral nerve coaptation. It uses an in situ polymerizing biopolymer platform to connect nerve ends, which helps to reduce mechanical stress at the site of the nerve repair.

Are the components of the Coaptium Connect system reusable?

The Coaptium Connect components are supplied sterile for single use only and must be discarded after the procedure. However, the Tissium Light component is a reusable, non-sterile device specifically designed to photoactivate the polymer.

How is the Coaptium Connect system supplied for clinical use?

The Coaptium Connect components are provided in double peel packages to maintain sterility until the time of use. They are available in a variety of sizes to accommodate different clinical requirements for nerve repair.

What is the regulatory status of this nerve repair device?

The Coaptium Connect with Tissium Light system has received FDA 510(k) authorization under K-number DEN240066. It is classified as a Class 2 medical device under regulation number 882.5270.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: How it works - COAPTIUM, COAPTIUM® Nerve Products - TISSIUM, COAPTIUM, COAPTIUM Connect with TISSIUM LIGHT (DEN240066) — FDA 510(k ..., COAPTIUM Connect with TISSIUM LIGHT (DEN240066) — FDA 510(k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Tissium SA

Sources (1)

  • FDA 510(k) DEN240066 24 fields · synced Sep 22, 2026