# K131072: Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire Straight Stiff, Orchestra Hydrophilic

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast A/S
- Decided: Jul 9, 2013 after 83 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). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923607: Radifocus Guide Wire M, Terumo Medical Corp. (1992) Summary page 2.

## Most influential descendants
- K150927: Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff (2015), 0 descendants of its own

## Indications for use
The hydrophilic guidewire is intended to facilitate the placement of devices through the urinary tract during endourologic procedures.

Source page: https://510kreport.com/device/K131072
Methodology: https://510kreport.com/methodology