# K171853: Liver Access and Biopsy Sets

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Aug 24, 2017 after 64 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- 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 K022634 (2002). 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)
- K022634: CO-Axial Introducer Needle, Promex, Inc. (2002) Summary page 4.

## Indications for use
The Liver Access and Biopsy Sets are intended for use in obtaining liver histology samples via jugular vein approach in adult and pediatric populations. The devices are intended to be used in the treatment of the following pediatric subgroups: infants, children, and adolescents.

Source page: https://510kreport.com/device/K171853
Methodology: https://510kreport.com/methodology