ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit) +3 more— 510(k) K252795
Substantially EquivalentArgon Medical Devices, Inc.
FDA 510(k) clearance K252795 for ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit) +3 more, Substantially Equivalent on 2026-02-23. Applicant: Argon Medical Devices, Inc.. Device class: 2.
Summary
Argon Medical Devices' ZeniCore Automatic Biopsy Instrument entries cover 12ga and 14ga sizes at 10cm and 13cm, and the first three name a coaxial introducer kit. The device name is cut off partway through the fourth entry. It's filed under product code KNW, biopsy instrument.
Class II, 21 CFR 876.1075. The General, Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology, Urology as the classification panel.
Argon Medical Devices filed from Athens, Texas. The decision came 174 calendar days after FDA received it (September 2, 2025 to February 23, 2026), and it was substantially equivalent.
Clearance details
- Device name as filed
- 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.
- Product code
- Product code KNW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Athens, TX, US
Recent devices under product code KNW
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- K241145 — TLAB® Transvenous Liver Biopsy System (TF-18C)
Adverse events under product code KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.