# 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

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast A/S
- Decided: May 27, 2015 after 51 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: 2 generations back to K923607 (1992). 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)
- K131072: Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire Straight Stiff, Orchestra Hydrophilic, Coloplast A/S (2013) Summary page 5.

## 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/K150927
Methodology: https://510kreport.com/methodology