# K193268: APrioCore Plus

- Pathway: 510(k) (Traditional)
- Applicant: Apriomed AB
- Decided: Feb 27, 2020 after 93 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: 1 generation back to K973565 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973565: Quick-Care Biopsy Needle, Cook, Inc. (1997) Summary page 4.

## Indications for use
AprioCore plus is intended for use in obtaining core biopsy specimens from soft tissue such as breast, kidney, liver, lung, thyroid, lymph nodes and various soft tissue masses performed under image guidance techniques for soft tissue biopsy.

Source page: https://510kreport.com/device/K193268
Methodology: https://510kreport.com/methodology