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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 K212079
Device Name TeesuVac Breast Biopsy Device Mark 1
Applicant
Teesuvac Aps
Agern Alle 3
Hoersholm,  DK DK-2970
Applicant Contact John Hvidkjaer
Correspondent
Teesuvac Aps
Agern Alle 3
Hoersholm,  DK DK-2970
Correspondent Contact John Hvidkjaer
Regulation Number876.1075
Classification Product Code
KNW  
Date Received07/02/2021
Decision Date 02/02/2022
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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