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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name In Situ Polymerizing Peripheral Nerve Repair Device
510(k) Number K251957
Device Name Coaptium Connect with Tissium Light
Applicant
Tissium SA
74 Rue Du Faubourg Saint Antoine
Paris,  FR 75012
Applicant Contact Bahija Ikched
Correspondent
Tissium SA
74 Rue Du Faubourg Saint Antoine
Paris,  FR 75012
Correspondent Contact Bahija Ikched
Classification Product Code
SFD  
Date Received06/25/2025
Decision Date 09/08/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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