# K061666: Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and Gastroflex

- Pathway: 510(k) (Special)
- Applicant: Mauna Kea Technologies
- Decided: Aug 24, 2006 after 71 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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: 4 generations back to K926514 (1993). 19 ancestors in all.
13 later devices descend from it; 2 cite it directly.
1 of 33 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042740: Isc-1000 Pentax Confocal Laser System, Pentax Medical Company (2004) Summary page 1.
- K042741: EC-3870CILK, Confocal Video Colonoscope, Pentax Medical Company (2004) Summary page 1.
- K042438: Superdimension/Bronchus, Superdimension, Ltd. (2004) Summary page 1.

## Most influential descendants
- K111047: Cellvizio 100 Series System with Confocal Miniprobes (2011), 12 descendants of its own
- 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

## Indications for use
The Cellvizio® (-GI, -LUNG) with Confocal MiniprobeTM (Coloflex, Gastroflex, Alveoflex) is a confocal laser imaging system with fiber optic probes that is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical tract, i.e., gastrointestinal or pulmonary, accessed by the endoscope.

Source page: https://510kreport.com/device/K061666
Methodology: https://510kreport.com/methodology