# K083330: Echotip Ultra Ultrasound Needle

- Pathway: 510(k) (Traditional)
- Applicant: Cook Endoscopy
- Decided: Feb 6, 2009 after 86 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: 4 generations back to K935844 (1995). 6 ancestors in all.
49 later devices descend from it; 9 cite it directly.
1 of 56 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070129: Sonotip II Ultrasound Needle System, Medi-Globe Corporation (2007) Summary page 1.
- K994151: Percutx-Injection/Aspiration Needle Probes/Devices, Ximed/Prosure/Injectx (2000) Summary page 1.
- K934356: Wilson-Cook GI Aspiration Needle, Wilson-Cook Medical, Inc. (1994) Summary page 1.

## Most influential descendants
- K092359: Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A (2009), 16 descendants of its own
- 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
- K111895: Echotip (R) Ultra Fiducial Needle (2012), 10 descendants of its own
- K142688: Echotip Procore HD Ultrasound Biopsy Needle (2014), 9 descendants of its own

## Indications for use
This device is intended to be used with an ultrasound endoscope for delivery of injectable materials into tissues during endoscopic procedures and fine needle aspirations (FNA) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the GI tract.

Source page: https://510kreport.com/device/K083330
Methodology: https://510kreport.com/methodology