# K150891: BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System

- Pathway: 510(k) (Special)
- Applicant: Covidien, LLC ( Formerly Beacon Endoscopic Corp.)
- Decided: May 1, 2015 after 29 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K935844 (1995). 21 ancestors in all.
3 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)
- K142198: BNX Fine Needle Aspiration System, Covidien, LLC (2014) Summary page 4.
- K141894: Sharkcore Fine Needle Biopsy System, Covidien, LLC ( Formerly Beacon Endoscopic Corp.) (2014) Summary page 4.

## Most influential descendants
- K163058: Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle (2017), 1 descendant 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
BNX Fine Needle Aspiration System: The device 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 (1.e., automatic) safety shielding feature to aid in the prevention of needle sticks. 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. SharkCore Fine Needle Biopsy System: The device 1s used with an ultrasound endoscope for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract. The needle is designed with a passive (1.e., automatic) safety shielding feature to aid in the prevention of needle sticks.

Source page: https://510kreport.com/device/K150891
Methodology: https://510kreport.com/methodology