# K022634: CO-Axial Introducer Needle

- Pathway: 510(k) (Traditional)
- Applicant: Promex, Inc.
- Decided: Nov 6, 2002 after 90 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K241145: TLAB® Transvenous Liver Biopsy System (TF-18C) (2024), 0 descendants of its own
- K171853: Liver Access and Biopsy Sets (2017), 0 descendants of its own

## Recalls of this device
- Dec 10, 2020 · Class II · Z-1074-2021: Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surg
- Dec 10, 2020 · Class II · Z-1077-2021: Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surg
- Dec 10, 2020 · Class II · Z-1072-2021: Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surg
- Dec 10, 2020 · Class II · Z-1073-2021: Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surg
- Dec 10, 2020 · Class II · Z-1076-2021: Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surg
- Dec 10, 2020 · Class II · Z-1075-2021: Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surg

## Indications for use
This device is intended to be used for percutaneous transjugular liver access during diagnostic and interventional procedures.

Source page: https://510kreport.com/device/K022634
Methodology: https://510kreport.com/methodology