# K091417: Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Corp.
- Decided: May 22, 2009 after 9 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: 3 generations back to K910722 (1991). 5 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021179: Disposable Guidewire, Models G-205-3545S & G-205-3545A, Olympus Optical Co., Ltd. (2002) Summary page 5.

## Most influential descendants
- K122505: Single Use Preloaded Sphincterotome V (2013), 7 descendants of its own
- K141991: Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SP (2015), 4 descendants of its own
- K192339: TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord (2020), 1 descendant of its own
- K150142: Single Use Balloon Dilator V (with Knife) (2015), 1 descendant of its own
- K250945: Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) (2025), 0 descendants of its own

## Indications for use
This instrument has been designed to be used with Olympus Endo-therapy Accessories. The instrument is used as guidewire of endoscopic accessories for biliary duct including not only common bile but cystic, pancreatic right and left hepatic duct.

Source page: https://510kreport.com/device/K091417
Methodology: https://510kreport.com/methodology