# K053028: Techdevice Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Techdevice Corporation
- Decided: Jan 31, 2006 after 96 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 K933334 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943737: Microvasive Pathfinder Exchange Guidewire Insurg Pathfinder Guidewire, Boston Scientific Corp (1994) Summary page 1.
- K935997: Platinum Plus Guidewire, Boston Scientific Corp (1994) Summary page 1.
- K933334: Magic Torque Guidewire, Boston Scientific Corp (1994) Summary page 1.

## Indications for use
The TechDevice Guidewire facilitates placement and exchange of catheters and other instruments in the alimentary tract. This device is not indicated for neuro or cardiac use.

Source page: https://510kreport.com/device/K053028
Methodology: https://510kreport.com/methodology