# K112945: Elitecore Full Core Biopsy Device 18GAX10CM, 18GAX15CM, 18GAX20, with/Hilitier 18GAX10CM , W/Hiliter 18GAX15CM

- Pathway: 510(k) (Special)
- Applicant: Inrad, Inc.
- Decided: Nov 3, 2011 after 30 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K904987 (1991). 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)
- K090611: Revolution Full Core Biopsy, Inrad (2009) Summary page 1.

## Recalls of this device
- Apr 24, 2015 · Class II · Z-1671-2015: Potential for the device cannula to overthrow past the intended length.

## Indications for use
The device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors.

Source page: https://510kreport.com/device/K112945
Methodology: https://510kreport.com/methodology