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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Magnetic Compression Anastomosis System
510(k) Number K243359
Device Name MagDI System (MAG-02, DS-01)
Applicant
Gt Metabolic Solutions, Inc.
3050 Three Springs Ct.
San Jose,  CA  95140
Applicant Contact Lisa Griffin Vincent
Correspondent
Gt Metabolic Solutions, Inc.
3050 Three Springs Ct.
San Jose,  CA  95140
Correspondent Contact Lisa Griffin Vincent
Classification Product Code
SAH  
Subsequent Product Code
GAD  
Date Received10/29/2024
Decision Date 02/28/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT06467955
NCT06613724
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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