# K132389: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked

- Pathway: 510(k) (Traditional)
- Applicant: Daniel & Daniel Consulting
- Decided: Feb 25, 2014 after 208 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: 7 generations back to K935844 (1995). 62 ancestors in all.
10 later devices descend from it; 2 cite it directly.
1 of 73 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111047: Cellvizio 100 Series System with Confocal Miniprobes, Mauna Kea Technologies, Inc. (2011) Summary page 1.
- K123676: Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes, Mauna Kea Technologies (2013) Summary page 1.
- K043022: Stryker Flexible Cystonephroscope, Stryker Endoscopy (2005) Summary page 1.
- K011496: Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts, Attchements, and Forceps Model 8650, 8652, 8660, Richard Wolf Medical Instruments Corp. (2001) Summary page 1.
- K091962: Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source, Model LS-200, Lumenis, Inc. (2009) Summary page 1.

## Most influential descendants
- 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
- K183640: Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes (2019), 4 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 are intended to allow imaging of the internal microstructure of tissues. The UroFlex™ B and CystoFlex™ F Confocal Miniprobes can be used within anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories. Confocal Miniprobes™ Endoscope or accessory UroFlex™ B Cystoscope or ureteroscope with operating channel internal diameter ≥ 1.0mm (3 Fr) CystoFlex™ F Flexible Cystoscope with operating channel internal diameter ≥ 1.0mm (3 Fr)

Source page: https://510kreport.com/device/K132389
Methodology: https://510kreport.com/methodology