ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit) +3 more— 510(k) K252795

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

Code KNW

Device class

Class 2

Regulation

21 CFR 876.1075

Advisory panel

Gastroenterology, Urology

Date received

2025-09-02

Decision date

2026-02-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Athens, TX, US

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Death

9

Injury

965

Malfunction

10,444

Other

3

Total

11,421

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →