# K972977: Insulator Wire Guide

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Oct 10, 1997 after 60 days
- Product code: KNY (Accessories, Catheter, G-U)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Protector Plus: named in the summary without a submission number

## Indications for use
The Insulator Wire Guide will be used either inside or alongside a urological catheter or electrosurgical catheter for catheter positioning or exchange in the urinary tract. When used with an electrosurgical catheter, the Insulator Wire Guide will decrease the risk of alternate site burns to the patient. This device is intended for one-time use.

Source page: https://510kreport.com/device/K972977
Methodology: https://510kreport.com/methodology