# K252795: 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

- Pathway: 510(k) (Traditional)
- Applicant: Argon Medical Devices, Inc.
- Decided: Feb 23, 2026 after 174 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K871390 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982960: Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy Instrument, Medical Device Technologies, Inc. (1998) Summary page 6.

## Indications for use
The ZeniCoreTM Automatic Biopsy Instrument and optional Co-Axial Introducer Needle is a single-use device indicated for obtaining core samples of soft tissue masses via percutaneous needle biopsy. It is not intended for use in bone.

Source page: https://510kreport.com/device/K252795
Methodology: https://510kreport.com/methodology