# K963565: Mri Needles

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Jul 14, 1997 after 312 days
- Product code: FCG (Biopsy Needle)
- 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 K882601 (1988). 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)
- K882601: E-Z-EM (R) Lufkin Biopsy Needles, E-Z-Em, Inc. (1988) Summary page 1.
- (no number) COOK INCORPORATED pre-Amendment and predicate disposable and reusable needles: named in the summary without a submission number
- (no number) devices marketed in Europe by William Cook Europe A/S: named in the summary without a submission number

## Indications for use
MRI needles are intended for use with 1.5 Tesla (or lower field strength) Magnetic Resonance Imaging procedures, including initial puncture, aspiration and injection, biopsies and diagnostic sampling.

Source page: https://510kreport.com/device/K963565
Methodology: https://510kreport.com/methodology