# K180270: Cellvizio 100 Series Systems with Confocal Miniprobes

- Pathway: 510(k) (Traditional)
- Applicant: Mauna Kea Technologies
- Decided: May 22, 2018 after 111 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002788 (2000). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161112: KARL STORZ Flexible Video-Neuro-Endoscope System, KARL STORZ Endoscopy-America, Inc. (2016) Summary page 4.

## Most influential descendants
- K191144: Cellvizio 100 Series System with Confocal Miniprobes (2020), 2 descendants of its own
- K181116: Convivo (2018), 1 descendant 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
- K211156: CONVIVO In Vivo Pathology Suite (2021), 0 descendants of its own
- K212322: Cellvizio I.V.E. system with Confocal Miniprobes (2021), 0 descendants of its own

## Indications for use
The 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 including, but not limited to, the identification of cells and vessels and their organization or architecture. The CranioFlex™ (-,-C) Confocal Miniprobes™ are indicated to provide visualization within central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.

Source page: https://510kreport.com/device/K180270
Methodology: https://510kreport.com/methodology