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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 K243095
Device Name Mammotome AutoCore™ Single Insertion Core Biopsy System
Applicant
Devicor Medical Products, Inc.
300 E- Business Way Fifth Floor
Cincinnati,  OH  45241
Applicant Contact Edenborg Jamie
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number876.1075
Classification Product Code
KNW  
Date Received09/30/2024
Decision Date 10/29/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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