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). This device is classified as 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 FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K252795 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2025 |
| Decision Date | February 23, 2026 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KNW — Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |