# K123676: Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes

- Pathway: 510(k) (Traditional)
- Applicant: Mauna Kea Technologies
- Decided: Apr 18, 2013 after 139 days
- Product code: OWN (Confocal Optical Imaging)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K935844 (1995). 22 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120208: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes, Mauna Kea Technologies (2012) Summary page 1.
- K112198: Expect Endoscopic Ultrasound Aspiration Needle, Boston Scientific Corporation (2011)
- K083330: Echotip Ultra Ultrasound Needle, Cook Endoscopy (2009) Summary page 1.
- K092359: Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A, Cook Ireland, Ltd. (2009) Summary page 1.

## Most influential descendants
- K132389: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked (2014), 10 descendants of its own
- K141358: Cellvizio 100 Series with System Confocal Miniprobes (2014), 9 descendants of its own
- K160416: CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes (2016), 7 descendants of its own
- K150831: Cellvizio 100 Series System with Confocal Miniprobes (2015), 7 descendants of its own
- K172844: Cellvizio 100 Series System with Confocal Miniprobes (2017), 6 descendants of its own

## Indications for use
The Cellvizio 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that is intended to allow imaging of the internal microstructure of tissues in anatomical tracts, i.e., gastrointestinal. The AQ-Flex 19TM member of the GastroFlex M series-of Confocal Miniprobes can be used within anatomical tracts. i.e., gastrointestinal. accessed by an endoscope or endoscopic accessories, including through EUS-FNA needles.

Source page: https://510kreport.com/device/K123676
Methodology: https://510kreport.com/methodology