# K180756: Safety Wire Guide Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: May 24, 2018 after 63 days
- Product code: EZN (Dilator, Catheter, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.5470
- 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 K851144 (1985). 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)
- K851144: Ureteral Dilation Set, Van-Tec, Inc. (1985) Summary page 4.

## Indications for use
The Safety Wire Guide Introducer is used for antegrade placement of a safety wire guide prior to endourological procedures.

Source page: https://510kreport.com/device/K180756
Methodology: https://510kreport.com/methodology