# K213232: NovaCore Semi-Automatic Biopsy Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Argon Medical Devices
- Decided: Jul 1, 2022 after 274 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: 2 generations back to K950732 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974814: Manan (TM) Super-Core Biopsy Needles, Medical Device Technologies, Inc. (1998) Summary page 4.

## Indications for use
The Semi-Automatic Biopsy Instrument and associated Co-Axial Introducer Needle are used to obtain samples from soft tissue such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, pancreas, and other masses.

Source page: https://510kreport.com/device/K213232
Methodology: https://510kreport.com/methodology