# K093399: Precisecore 10 MM Biopsy Device- 14GA X 5 CM Model 670514, 671014, 670518 671018, 670520

- Pathway: 510(k) (Traditional)
- Applicant: Inrad
- Decided: Nov 19, 2009 after 17 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 K994272 (2000). 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)
- K994272: Automated Core Biopsy Device, Promex, Inc. (2000) Summary page 1.

## Indications for use
The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. For breast biopsy this product is for diagnosis only - not for therapeutic use.

Source page: https://510kreport.com/device/K093399
Methodology: https://510kreport.com/methodology