510(k) · Cleared
ClearedCellvizio 100 Series Systems with Confocal Miniprobes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mauna Kea Technologies · GWG Endoscope, Neurological
Cleared on May 22, 2018 as substantially equivalent to K161112 (KARL STORZ Endoscopy-America, Inc., 2016) after a 111-day review. Its family tree reaches back 2 generations to 2000. 5 later devices descend from it.
- Decided
- May 22, 2018
- Review
- 111 days
- Class
- Class II
- Product code
- GWG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002788 (2000). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK002788 Ksea Neuro-FiberscopeKARL STORZ Endoscopy-America, Inc. · 2000 · Recalled
- 1 generation backK161112 KARL STORZ Flexible Video-Neuro-Endoscope SystemKARL STORZ Endoscopy-America, Inc. · 2016
- This deviceK180270 Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies · 2018
- Descendant · cites it directly · 2 of its ownK191144 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2020
- Descendant · cites it directly · 1 of its ownK181116 ConvivoCarl Zeiss Meditec, AG · 2018
- Descendant · 2 generations on · 0 of its ownK243711 Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe…Wuxi Hisky Medical Technologies Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK211156 CONVIVO In Vivo Pathology SuiteCarl Zeiss Meditec, AG · 2021
- Descendant · 2 generations on · 0 of its ownK212322 Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies · 2021
Most influential descendants
Showing 5 of 5 · See all- K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2020 · cites it directly2descendants
- K181116ConvivoCarl Zeiss Meditec, AG · 2018 · cites it directly1descendant
- K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd. · 2025 · 2 generations on0descendants
- K211156CONVIVO In Vivo Pathology SuiteCarl Zeiss Meditec, AG · 2021 · 2 generations on0descendants
- K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002788 | Ksea Neuro-Fiberscope | KARL STORZ Endoscopy-America, Inc. | 2000 | 4 |
| −1 | K161112 | KARL STORZ Flexible Video-Neuro-Endoscope System | KARL STORZ Endoscopy-America, Inc. | 2016 | — |
| 0 (this device) | K180270 | Cellvizio 100 Series Systems with Confocal Miniprobes | Mauna Kea Technologies | 2018 | — |
| +1 | K191144 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2020 | — |
| +1 | K181116 | Convivo | Carl Zeiss Meditec, AG | 2018 | — |
| +2 | K243711 | Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging… | Wuxi Hisky Medical Technologies Co., Ltd. | 2025 | — |
| +2 | K211156 | CONVIVO In Vivo Pathology Suite | Carl Zeiss Meditec, AG | 2021 | — |
| +2 | K212322 | Cellvizio I.V.E. system with Confocal Miniprobes | Mauna Kea Technologies | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GWG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GWG device
- #1 K211202 1688 4K Camera System, L11 LED Light Source…score 22.5 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K161112 | KARL STORZ Flexible Video-Neuro-Endoscope SystemSummary page 4…): Neurological Endoscope Classification: Class II Predicate Device: • KARL STORZ Flexible Video-Neuro-Endoscope System (K161112). Reference devices: • The Cellvizio® 100 Series System with Confocal Miniprobes™ cleared via K172844… | 2016 |
| † | K172844 | Cellvizio 100 Series System with Confocal Miniprobes | 2017 |
| † | K111047 | Cellvizio 100 Series System with Confocal Miniprobes | 2011 |
| † | K150831 | Cellvizio 100 Series System with Confocal Miniprobes | 2015 |
| † | K133466 | Cellvizio 100 Series System with Confocal Miniprobes (TM) | 2014 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 15.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K191144 (Mauna Kea Technologies, 2020) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GWG devicesGWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · GWG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWG
269in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWG
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWG
33in 2025
MAUDE reports naming product code GWG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 2 | 4 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 19 |
| 2015 | 0 | — | 0 | 37 |
| 2016 | 2 | — | 0 | 25 |
| 2017 | 4 | 126 | 0 | 12 |
| 2018 | 4 | 128 | 0 | 16 |
| 2019 | 3 | 156 | 0 | 10 |
| 2020 | 2 | — | 0 | 19 |
| 2021 | 3 | 106 | 0 | 21 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 5 | 269 | 0 | 9 |
| 2024 | 1 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 33 |
| 2026 | 4 | 217 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180270 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180270: Cellvizio 100 Series Systems with Confocal Miniprobes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180270
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026