# K093195: Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-O

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: Jan 21, 2010 after 104 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: 9 generations back to K894632 (1989). 62 ancestors in all.
8 later devices descend from it; 1 cites it directly.
2 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050503: Single Use Aspiration Needle NA-201SX-4022, Olympus Medical Systems Corporation (2005) Summary page 1.
- K083330: Echotip Ultra Ultrasound Needle, Cook Endoscopy (2009) Summary page 1.

## Most influential descendants
- K160229: Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle (2016), 7 descendants of its own
- K210476: EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle (2021), 2 descendants of its own
- K193517: ViziShot 2 FLEX (2020), 2 descendants of its own
- K230909: EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) (2023), 1 descendant of its own
- K261274: EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes (2026), 0 descendants of its own

## Indications for use
This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract through the accessory channel of an ultrasound endoscope for Fine Needle Aspiration (FNA).

Source page: https://510kreport.com/device/K093195
Methodology: https://510kreport.com/methodology