# K021179: Disposable Guidewire, Models G-205-3545S & G-205-3545A

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Optical Co., Ltd.
- Decided: Jul 5, 2002 after 81 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 K910722 (1991). 4 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933110: Olympus Guide Wire, Olympus Corp. (1993) Summary page 4.
- K971937: Climber - Partially Coated Guide Wire for Endoscopic Use, Terumo Medical Corp. (1997) Summary page 4.
- K922302: Jagwire (TM) Recanalization Guidewire, Boston Scientific Corp (1992) Summary page 4.

## Most influential descendants
- 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 (2009), 8 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K021179
Methodology: https://510kreport.com/methodology