# K261274: EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: Jul 24, 2026 after 98 days
- Product code: KTI (Bronchoscope Accessory)
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K894632 (1989). 69 ancestors in all.
No later device cites it as a predicate yet.
2 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193517: ViziShot 2 FLEX, Olympus Surgical Technologies America (2020) Summary page 5.

## Indications for use
EchoTip Ultra® Endobronchial HD Ultrasound Needle for Fujifilm 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 HD Ultrasound Biopsy Needle for Fujifilm 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/K261274
Methodology: https://510kreport.com/methodology