# K060034: Nipro Hydrophilic Guidewire for Urological & Laparoscopic Use

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corporation
- Decided: Feb 28, 2006 after 54 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 K923607 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001251: Sniper, Model or-3872XX Series, Nipro Medical Corp. (2000) Summary page 1.
- K926214: Guide Wire for Laporoscopic Use, Terumo Medical Corp. (1993) Summary page 1.
- K923607: Radifocus Guide Wire M, Terumo Medical Corp. (1992) Summary page 1.

## Indications for use
The Nipro Hydrophilic Guidewires are designed for use in urological, laparoscopic, and radiological procedmes where a smooth guidewire is desired to introduce/position catheters, direct and maintain access, and be used to guide and exchange endoscopic accessories.

Source page: https://510kreport.com/device/K060034
Methodology: https://510kreport.com/methodology