# K961897: Wilson-Cook Biliary Introducer with Aspiration Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jan 29, 1997 after 258 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Wilson-Cook Biliary and Gastric Aspiration Needle: named in the summary without a submission number

## Most influential descendants
- K160890: Howell Biliary Introducer Needle (2017), 0 descendants of its own

## Indications for use
The Wilson-Cook Biliary Introducer with Aspiration Biopsy Needle is used for aspiration biopsy in the biliary system, and if desired for the introduction of other biopsy instruments.

Source page: https://510kreport.com/device/K961897
Methodology: https://510kreport.com/methodology