# K180037: Beacon EUS Access System

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Apr 26, 2018 after 111 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K935844 (1995). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 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.
- K092359: Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A, Cook Ireland, Ltd. (2009) Summary page 4.

## Recalls of this device
- Jun 26, 2020 · Class II · Z-2769-2020: This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. 
- Jun 26, 2020 · Class II · Z-2768-2020: This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. 

## Indications for use
The Beacon EUS Access System is used to access the following areas of the gastrointestinal tract: the intra- or extra-hepatic bile ducts, pancreatic ducts, cystic duct, gallbladder or for delivery of injectable materials into tissues through the accessory channel of an ultrasound endoscope.

Source page: https://510kreport.com/device/K180037
Methodology: https://510kreport.com/methodology