# K990765: Flexfinder Guide Wire (Regular Shaft/Stiff Shaft) Marked Ink Bands, Flexfinder Guide Wire (Regular Shaft/Stiff Shaft) NO

- Pathway: 510(k) (Special)
- Applicant: Flexmedics
- Decided: Mar 15, 1999 after 7 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The FlexFinder® ENCAP guidewire is designed to be used to guide and exchange edoscopic accessories and electrosurgical devices for biliary procedures. The FlexFinder guidewire is indicated for selective cannulation of the biliary ducts, including, but not limited to the common bile, cystic, pancreatic, and right and left hepatic ducts.

Source page: https://510kreport.com/device/K990765
Methodology: https://510kreport.com/methodology