# K243061: SonoStik Guide Wire Introducer

- Pathway: 510(k) (Special)
- Applicant: Sonostik, LLC
- Decided: Nov 4, 2024 after 38 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: 7 generations back to K954234 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152177: SonoStik IV Guide Wire Introducer, Sonostik, LLC (2015) Summary page 5.

## Indications for use
The SonoStik Guide Wire Introducer is used to facilitate the introduction of a guide wire and catheter through the skin into a vein or artery of the peripheral vasculature. The SonoStik Guide Wire Introducer is not intended for use in the coronary arteries or neurovasculature.

Source page: https://510kreport.com/device/K243061
Methodology: https://510kreport.com/methodology