# K033754: Tracer Metro Smart Wire Guide

- Pathway: 510(k) (Special)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Dec 30, 2003 after 29 days
- Product code: OCY (Endoscopic Guidewire, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K910497 (1991). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910497: Wilson Cook Wire Guide and Protective Guide, Wilson-Cook Medical, Inc. (1991) Summary page 4.

## Most influential descendants
- K122816: Axcess Soft Tip Wire Guide (2012), 3 descendants of its own
- K133076: Novagold High Performance Guidewire (2014), 1 descendant of its own
- K150225: NovaGold High Performance Guidewire (2015), 0 descendants of its own
- K142950: Acrobat Calibrated Tip Wire Guide (2014), 0 descendants of its own

## Indications for use
The Tracer Metro Smart Wire Guide is intended to assist in cannulation of the billary and pancreatic ducts and to aid in bridging difficult strictures during ERCP.

Source page: https://510kreport.com/device/K033754
Methodology: https://510kreport.com/methodology