# K142688: Echotip Procore HD Ultrasound Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: Dec 19, 2014 after 88 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: 5 generations back to K935844 (1995). 10 ancestors in all.
9 later devices descend from it; 3 cite it directly.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083330: Echotip Ultra Ultrasound Needle, Cook Endoscopy (2009) Summary page 5.
- K021847: Biopsy Sciences, LLC. Maxi-Cell Biopsy Needles, Biopsy Sciences, LLC (2002) Summary page 5.

## 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 with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.

Source page: https://510kreport.com/device/K142688
Methodology: https://510kreport.com/methodology