# K193517: ViziShot 2 FLEX

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Surgical Technologies America
- Decided: Mar 18, 2020 after 90 days
- Product code: KTI (Bronchoscope Accessory)
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K894632 (1989). 68 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160229: Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle, Cook Ireland, Ltd. (2016) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Aug 6, 2025 · Class I · Z-2484-2025: Potential for undetected, deformed a-traumatic tips.

## Indications for use
The ViziShot 2 FLEX has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) 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/K193517
Methodology: https://510kreport.com/methodology