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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 K260572
Device Name Marrow Marxman
Applicant
Medimetrix, LLC
3012 Centre Oak Way
Suite 102
Germantown,  TN  38138
Applicant Contact Brian Austin
Correspondent
MRC Global
9160 Hwy. 64, Suite 12
P.O. Box 330
Lakeland,  TN  38002
Correspondent Contact Christine Scifert
Regulation Number876.1075
Classification Product Code
KNW  
Date Received02/19/2026
Decision Date 08/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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