# K163469: ViziShot 2 FLEX

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Surgical Technologies America
- Decided: Apr 6, 2017 after 115 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: 11 generations back to K894632 (1989). 57 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 63 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152922: ViziShot FLEX, Spiration, Inc. (2016) Summary page 4.

## Most influential descendants
- K190239: Single Use Aspiration Needle (2019), 2 descendants of its own
- K213060: AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle (2022), 1 descendant of its own
- K251478: ClearTip TBNA Type (2026), 0 descendants of its own
- K251664: Single Use Aspiration Needle  (NA-201SX-4021); Single Use Aspiration Needle  (NA-201SX-4022) (2025), 0 descendants of its own
- K230778: EndoCore (2023), 0 descendants of its own

## Indications for use
The ViziShot 2 FLEX has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use.

Source page: https://510kreport.com/device/K163469
Methodology: https://510kreport.com/methodology