Argon Medical Devices, Inc. · Class II · Cleared Feb 23, 2026
| K-number | K252795 |
| Device name | 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 | KNW |
| Device class | Class II |
| Decision date | Feb 23, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 876.1075 |
The ZeniCore™ Automatic Biopsy Instrument is a single-use, spring-loaded medical device designed to obtain core tissue samples from soft tissue masses via percutaneous needle biopsy under imaging guidance (ultrasound, fluoroscopy, or CT). It is available in multiple needle gauges (12G–20G) and lengths (10–25 cm) and can be used standalone or with an optional coaxial introducer needle. The device is not intended for bone biopsies.
The device features a 25 mm throw length with a 19 mm sample notch, available in five needle gauge sizes identified by color-coded buttons. It includes an echogenic tip with centimeter markings for depth placement and operates in both semi-automatic and automatic modes. The optional coaxial introducer needle has an adjustable spring clip locking mechanism and color-coded Luer hubs matching the biopsy instrument gauges. All components are sterilized via ethylene oxide (EtO) to a minimum sterility assurance level (SAL) of 10⁻⁶.
ISO 10993-1:2018 for biocompatibility; ISO 10993-5, -10, -11, -23, and -4 for cytotoxicity, sensitization, pyrogenicity, irritation, and hemolysis testing. Non-clinical testing included visual, dimensional, puncture force, resistance to breakage, charging and firing forces, simulated use in ex vivo tissues, tensile strength, package integrity, tissue composition analysis, radiopacity, echogenicity, corrosion, and design validation.
Substantial equivalence is based on comparable indications for use (soft tissue core biopsies), identical intended use and mechanism of action (spring-loaded mechanical sampling), same sterilization method (EtO), same sample retrieval method (cutting cannula), equivalent visualization techniques, comparable technological characteristics, and biocompatible materials meeting ISO standards. Performance testing in ex vivo tissue demonstrated equivalence to the predicate Tru-Core II device (K982960) and reference devices Marquee™ (K133948) and coaxial introducer needle (K980004).
View the full FDA submission: accessdata.fda.gov