# K103668: BNX Fine Needle Aspiration System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Endoscopic Engineering
- Decided: Dec 30, 2010 after 14 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K935844 (1995). 12 ancestors in all.
8 later devices descend from it; 1 cites 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)
- K083330: Echotip Ultra Ultrasound Needle, Cook Endoscopy (2009) Summary page 1.
- K023272: Disposable Aspiration Needle NA-200H, The Olympus Optical Co. (2002) Summary page 1.

## Most influential descendants
- K133008: BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25 Gauge Needles (Individually Sterile-Packed, (2013), 7 descendants of its own
- 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

## Recalls of this device
- Feb 8, 2017 · Class II · Z-1475-2017: Handle may break during use.
- Feb 8, 2017 · Class II · Z-1473-2017: Handle may break during use.
- Feb 8, 2017 · Class II · Z-1476-2017: Handle may break during use.
- Feb 8, 2017 · Class II · Z-1474-2017: Handle may break during use.
- Feb 8, 2017 · Class II · Z-1472-2017: Handle may break during use.

## Indications for use
The BNX Fine Needle Aspiration System is used to sample targeted sub-mucosal and extramural lesions of the gastrointestinal tract through the accessory channel of an ultrasound endoscope.

Source page: https://510kreport.com/device/K103668
Methodology: https://510kreport.com/methodology