# K152586: Beacon Fine Needle Fiducial System

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Dec 30, 2015 after 111 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: 9 generations back to K935844 (1995). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150891: BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System, Covidien, LLC ( Formerly Beacon Endoscopic Corp.) (2015) Summary page 4.

## Indications for use
The Beacon Fine Needle Fiducial System is intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures. The needle is designed with a passive (i.e. automatic) safety shielding feature to aid in the prevention of needle stick injury.

Source page: https://510kreport.com/device/K152586
Methodology: https://510kreport.com/methodology