# K092359: Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: Nov 2, 2009 after 90 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 1 (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.
16 later devices descend from it; 4 cite it directly.
0 of 29 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.
- K022595: Wilson-Cook Cystotome, Wilson-Cook Medical, Inc. (2002) Summary page 1.

## Most influential descendants
- K123676: Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes (2013), 11 descendants of its own
- K132389: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked (2014), 10 descendants of its own
- K141358: Cellvizio 100 Series with System Confocal Miniprobes (2014), 9 descendants of its own
- K160416: CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes (2016), 7 descendants of its own
- K150831: Cellvizio 100 Series System with Confocal Miniprobes (2015), 7 descendants of its own

## Recalls of this device
- Apr 1, 2024 · Class II · Z-1832-2024: Devices may contain elevated levels of bacterial endotoxin.

## Indications for use
This device is used to access or sample submucosal and extramural lesions of the gastrointestinal tract, access of the following: 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/K092359
Methodology: https://510kreport.com/methodology