# K223300: Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Geotek Medikal Ltd Sti
- Decided: Apr 21, 2023 after 176 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Geotek Disposable Core Biopsy Needles (Three Models: Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, and Maxicore-M Automatic Biopsy Needle and Instrument) are intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not Intended for use in bone.

Source page: https://510kreport.com/device/K223300
Methodology: https://510kreport.com/methodology