# K023603: Endo-Glide Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Endo-Therapeutics, Inc.
- Decided: Feb 19, 2003 after 114 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 K931650 (1993). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922302: Jagwire (TM) Recanalization Guidewire, Boston Scientific Corp (1992) Summary page 4.
- K964955: Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands Encap+/Guidewire (Regular Shaft/Stiff Shaft) NO Marking, Flexmedics (1997) Summary page 4.
- K011759: Radius Next Generation Guidewire, Radius Medical Technologies, Inc. (2001) Summary page 4.

## Most influential descendants
- K051068: Zutron Colonoscope Stiffening Device (2005), 1 descendant of its own
- K251204: FUJIFILM Stiffening Wire Device (SW-2000) (2025), 0 descendants of its own

## Indications for use
Endo-Glide Guidewires are intended to be used for selective cannulization of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.

Source page: https://510kreport.com/device/K023603
Methodology: https://510kreport.com/methodology