# K971498: Applied Medical Laparoscopic Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources
- Decided: May 5, 1997 after 10 days
- Product code: EZB (Stylet For Catheter, Gastro-Urology)
- Device class: 1
- Regulation: 21 CFR 876.5130
- 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 K880100 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944135: Urological Guidwire, Applied Medical Resources (1994) Summary page 1.
- K880100: Cook Urological Wire Guide W/Hydromer Coating, Cook Urological, Inc. (1988) Summary page 1.

## Indications for use
The Applied Medical Laparoscopic Guidewire is intended to assist the physician in navigation, placement and exchange of laparoscopic and general surgical instrumentation.

Source page: https://510kreport.com/device/K971498
Methodology: https://510kreport.com/methodology