# K160229: Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: Mar 21, 2016 after 49 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: 10 generations back to K894632 (1989). 67 ancestors in all.
7 later devices descend from it; 3 cite it directly.
2 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093195: Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-O, Cook Ireland, Ltd. (2010) Summary page 5.
- K142688: Echotip Procore HD Ultrasound Biopsy Needle, Cook Ireland, Ltd. (2014) Summary page 5.

## Most influential descendants
- 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
- K251402: LIA-1 Catheter (542-1) (2025), 0 descendants of its own

## Indications for use
Echotip® Ultra Endobronchial High Definition Ultrasound Needle for use with Olympus EBUS scopes: 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). Echotip® Ultra Endobronchial High Definition Ultrasound Needle for use with Pentax EBUS scopes: This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree through the accessory channel of an ultrasound endoscope for Fine Needle Aspiration (FNA). Echotip Procore® Endobronchial High Definition Ultrasound Biopsy Needle for use with Olympus EBUS scopes: This device is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract. Echotip Procore® Endobronchial High Definition Ultrasound Biopsy Needle for use with Pentax EBUS scopes: This device is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal and extramural lesions within or adjacent to the tracheobronchial tree.

Source page: https://510kreport.com/device/K160229
Methodology: https://510kreport.com/methodology