Coaptium Connect with Tissium Light

FDA 510(k) K251957 · Tissium SA

Substantially Equivalent

510(k) numberK251957

Submission

Device name
Coaptium Connect with Tissium Light
Applicant
Tissium SA
Paris, FR
Received
June 25, 2025
Decision date
September 8, 2025
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
SFD – In Situ Polymerizing Peripheral Nerve Repair Device
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5270
Specialty
Neurology
Implant
Yes

An in situ polymerizing peripheral nerve repair device is intended for the sutureless repair of peripheral nerve injuries.

Questions and answers

When was Coaptium Connect with Tissium Light cleared by the FDA?

Coaptium Connect with Tissium Light (K251957) received a 510(k) decision of Substantially Equivalent on September 8, 2025, 75 days after the submission was received.

What is the product code of K251957?

The FDA product code is SFD – In Situ Polymerizing Peripheral Nerve Repair Device, a Class II (moderate risk) device regulated under 21 CFR 882.5270.