About This 510(k) Submission
K252795 is an FDA 510(k) clearance for the 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, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on February 23, 2026, 174 days after receiving the submission on September 2, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1075.