# K142198: BNX Fine Needle Aspiration System

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Oct 8, 2014 after 58 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: 7 generations back to K935844 (1995). 19 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133008: BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25 Gauge Needles (Individually Sterile-Packed,, Beacon Endoscopic (2013) Summary page 4.
- K111895: Echotip (R) Ultra Fiducial Needle, Wilson-Cook Medical Inc./Cook Endoscopy (2012) Summary page 4.

## Most influential descendants
- K150891: BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System (2015), 3 descendants of its own
- K163058: Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle (2017), 1 descendant of its own
- K180037: Beacon EUS Access System (2018), 0 descendants of its own
- K173184: Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle (2017), 0 descendants of its own
- K152586: Beacon Fine Needle Fiducial System (2015), 0 descendants of its own

## Indications for use
The BNX FNA System is used to sample targeted sub-mucosal and extramural gastrointestinal lesions through the accessory channel of an ultrasound endoscope. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle stick injury. The 19Ga. and 22Ga. BNX Aspiration Needles are also intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.

Source page: https://510kreport.com/device/K142198
Methodology: https://510kreport.com/methodology