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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 K162588
Device Name Möller Medical Biopsy Needles and Systems
Applicant
Moller Medical GmbH
Wasserkuppenstrabe 29-31
Fulda,  DE 36043
Applicant Contact Christoph Traxler
Correspondent
Moller Medical GmbH
Wasserkuppenstrabe 29-31
Fulda,  DE 36043
Correspondent Contact Angela Kikowatz
Regulation Number876.1075
Classification Product Code
KNW  
Date Received09/16/2016
Decision Date 06/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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