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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 K163052
Device Name Brevera Biopsy System with Corlumina Imaging Technology
Applicant
Hologic, Inc.
250 Campus Dr.
Malborough,  MA  01752
Applicant Contact SARAH FAIRFIELD
Correspondent
Hologic, Inc.
250 Campus Dr.
Malborough,  MA  01752
Correspondent Contact SARAH FAIRFIELD
Regulation Number876.1075
Classification Product Code
KNW  
Date Received11/01/2016
Decision Date 03/29/2017
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
Recalls CDRH Recalls
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