# K011759: Radius Next Generation Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Radius Medical Technologies, Inc.
- Decided: Aug 23, 2001 after 78 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: 1 generation back to K942677 (1994). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942677: Geenen/Zebra Guidelines, Boston Scientific Corp (1994) Summary page 4.
- (no number) Boston Scientific Microvasive Jagwire: named in the summary without a submission number

## Most influential descendants
- K023603: Endo-Glide Guidewire (2003), 2 descendants of its own
- K051068: Zutron Colonoscope Stiffening Device (2005), 1 descendant of its own
- K251204: FUJIFILM Stiffening Wire Device (SW-2000) (2025), 0 descendants of its own
- K050304: FX Wire Advanced Measurement Guidewire (2005), 0 descendants of its own

## Indications for use
The Next Generation Guidewire is designed to be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The guidewire is indicated for selective cannulation of the biliary ducts, including but-not limited to the common bile duct, cystic, pancreatic, and right and left hepatic ducts.

Source page: https://510kreport.com/device/K011759
Methodology: https://510kreport.com/methodology