# K160890: Howell Biliary Introducer Needle

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jun 14, 2017 after 440 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 K961897 (1997). 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)
- K961897: Wilson-Cook Biliary Introducer with Aspiration Biopsy Needle, Wilson-Cook Medical, Inc. (1997) Summary page 4.

## Indications for use
The Howell Biliary Introducer Needle is used for aspiration biopsy in the biliary system.

Source page: https://510kreport.com/device/K160890
Methodology: https://510kreport.com/methodology