510(k) K252795 · KNW Instrument, Biopsy
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 (863214
| Applicant | Argon Medical Devices, Inc., Athens TX, US |
| Decision | Substantially Equivalent, Feb 23, 2026 |
| Received | Sep 2, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252795
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.