# K072354: Guidewire, Model G-V220-3527S and Others

- Pathway: 510(k) (Traditional)
- Applicant: Accellent, Inc.
- Decided: Dec 7, 2007 after 107 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.
No later device cites it as a predicate yet.
0 of 6 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)

## Indications for use
This instrument has been designed to be used with the Olympus endo-therapy Accessories. The instrument is used for the guiding and exchanging endoscopic accessories for the biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.

Source page: https://510kreport.com/device/K072354
Methodology: https://510kreport.com/methodology