# K160416: CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes

- Pathway: 510(k) (Special)
- Applicant: Mauna Kea Technologies
- Decided: May 20, 2016 after 94 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: 9 generations back to K935844 (1995). 71 ancestors in all.
7 later devices descend from it; 1 cites it directly.
1 of 79 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141358: Cellvizio 100 Series with System Confocal Miniprobes, Mauna Kea Technologies (2014) Summary page 4.
- K151593: Cellvizio 100 Series System with Confocal Miniprobes, Mauna Kea Technologies (2015) Summary page 4.

## Most influential descendants
- 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
- K191144: Cellvizio 100 Series System with Confocal Miniprobes (2020), 2 descendants of its own
- K243711: Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); (2025), 0 descendants of its own
- K241275: Histolog® Scanner  (Hardware 2.4, Software 3.3) (2024), 0 descendants of its own

## Indications for use
Cellvizio® 100 Series Systems with Confocal Miniprobes™ are confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues. CelioFlex™ UHD 5-C Confocal Miniprobe is intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures. CystoFlex™ UHD R-C Confocal Miniprobe 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.

Source page: https://510kreport.com/device/K160416
Methodology: https://510kreport.com/methodology