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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 K243886
Device Name ExpressCore Biopsy Device
Applicant
Inrad, Inc.
4375 Donker Ct. SE
Kentwood,  MI  49512
Applicant Contact Heidi Halverson
Correspondent
Inrad, Inc.
4375 Donker Ct. SE
Kentwood,  MI  49512
Correspondent Contact Heidi Halverson
Regulation Number876.1075
Classification Product Code
KNW  
Date Received12/18/2024
Decision Date 04/29/2025
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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