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510(k) DEN240066

COAPTIUM Connect with TISSIUM LIGHT by Tissium SA — Product Code SFD

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: June 17, 2025
Date Received: November 21, 2024
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: In Situ Polymerizing Peripheral Nerve Repair Device
Device Class: Class II
Regulation Number: 882.5270
Review Panel: NE
Submission Type

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