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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K193268
Device Name APrioCore Plus
Applicant
Apriomed AB
Virdings Alle 28
Uppsala,  SE 75450
Applicant Contact Katrin Svensson
Correspondent
Apriomed AB
Virdings Alle 28
Uppsala,  SE 75450
Correspondent Contact Katrin Svensson
Regulation Number876.1075
Classification Product Code
KNW  
Date Received11/26/2019
Decision Date 02/27/2020
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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