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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K230058
Device Name Bladeless Trocar – Artemis Lap Cannula
Applicant
T.A.G. Medical Products Corporation, Ltd.
T.A.G. Medical Products Corporation, Ltd
Gaaton,  IL 2513000
Applicant Contact Shlomi Dines
Correspondent
T.A.G. Medical Products Corporation, Ltd.
T.A.G. Medical Products Corporation, Ltd
Gaaton,  IL 2513000
Correspondent Contact Shlomi Dines
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/09/2023
Decision Date 04/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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