# K133008: BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25 Gauge Needles (Individually Sterile-Packed,

- Pathway: 510(k) (Traditional)
- Applicant: Beacon Endoscopic
- Decided: Nov 20, 2013 after 56 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: 6 generations back to K935844 (1995). 13 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103668: BNX Fine Needle Aspiration System, Boston Endoscopic Engineering (2010) Summary page 1.

## Most influential descendants
- K142198: BNX Fine Needle Aspiration System (2014), 5 descendants of its own
- K141894: Sharkcore Fine Needle Biopsy System (2014), 4 descendants of its own
- 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

## Indications for use
The BNX FNA System is used to sample targeted sub-mucasal 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.

Source page: https://510kreport.com/device/K133008
Methodology: https://510kreport.com/methodology