# K213060: AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: Jul 20, 2022 after 301 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). 58 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 60 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163469: ViziShot 2 FLEX, Olympus Surgical Technologies America (2017) Summary page 5.

## Most influential descendants
- K230778: EndoCore (2023), 0 descendants of its own

## Indications for use
The Endobronchial Ultrasound Aspiration Needle is used with ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree.

Source page: https://510kreport.com/device/K213060
Methodology: https://510kreport.com/methodology