# K141356: Echo Tip Ultra Fiducial Needle

- Pathway: 510(k) (Special)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jun 20, 2014 after 28 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K935844 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111895: Echotip (R) Ultra Fiducial Needle, Wilson-Cook Medical Inc./Cook Endoscopy (2012) Summary page 1.

## Indications for use
Intended to implant fiducials under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.

Source page: https://510kreport.com/device/K141356
Methodology: https://510kreport.com/methodology