# K973215: Stereotactic Needle Core Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: Laurus Medical Corp.
- Decided: Nov 6, 1997 after 71 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
The Laurus Medical Stereotactic Needle Core Biopsy System is to be used in conjunction with Stereotactic Imaging Tables to obtain needle core biopsy samples from soft tissue percutaneously.

Source page: https://510kreport.com/device/K973215
Methodology: https://510kreport.com/methodology