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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K253620
Device Name TroClose 1200
Applicant
Gordian Surgical, Ltd.
Tchelet St. 17, Misgav Industrial Park
Misgav,  IL 2017400
Applicant Contact Eddie Shaw
Correspondent
Avio Medtech Consulting
2300 Myrtle Ave.
Suite 200
St Paul,  MN  55114
Correspondent Contact Matthieu Kirkland
Regulation Number878.4493
Classification Product Code
GAM  
Subsequent Product Code
GCJ  
Date Received11/18/2025
Decision Date 12/16/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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