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510(k) K251957

Coaptium Connect with Tissium Light by Tissium SA — Product Code SFD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 8, 2025
Date Received: June 25, 2025
Clearance Type: Special
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.