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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 K252795
Device Name ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial
Applicant
Argon Medical Devices, Inc.
1445 Flat Creek Rd.
Athens,  TX  75751
Applicant Contact Jacquelyn Huyghue
Correspondent
Argon Medical Devices, Inc.
1445 Flat Creek Rd.
Athens,  TX  75751
Correspondent Contact Jacquelyn Huyghue
Regulation Number876.1075
Classification Product Code
KNW  
Date Received09/02/2025
Decision Date 02/23/2026
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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