# K111895: Echotip (R) Ultra Fiducial Needle

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical Inc./Cook Endoscopy
- Decided: Apr 27, 2012 after 297 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: 5 generations back to K935844 (1995). 11 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042296: Biomarc Preloaded Tissue Marker Device, Carbon Medical Technologies, Inc. (2004) Summary page 1.
- K083330: Echotip Ultra Ultrasound Needle, Cook Endoscopy (2009) Summary page 1.

## Most influential descendants
- K142198: BNX Fine Needle Aspiration System (2014), 5 descendants of its own
- K150891: BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System (2015), 3 descendants of its own
- K132708: Biomarc Fiducial Marker (2013), 2 descendants of its own
- K163058: Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle (2017), 1 descendant of its own
- K191797: BiomarC Fiducial Marker (2019), 0 descendants of its own

## 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/K111895
Methodology: https://510kreport.com/methodology