510(k) · Cleared
Recalled · Class II · 2019Ksea Neuro-Fiberscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · GWG Endoscope, Neurological
Cleared on Oct 23, 2000 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 23, 2000
- Review
- 46 days
- Class
- Class II
- Product code
- GWG
- Recalls
- 4
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK002788 Ksea Neuro-FiberscopeKARL STORZ Endoscopy-America, Inc. · 2000
- Descendant · cites it directly · 6 of its ownK161112 KARL STORZ Flexible Video-Neuro-Endoscope SystemKARL STORZ Endoscopy-America, Inc. · 2016
- Descendant · 2 generations on · 5 of its ownK180270 Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies · 2018
- Descendant · 3 generations on · 2 of its ownK191144 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2020
- Descendant · 3 generations on · 1 of its ownK181116 ConvivoCarl Zeiss Meditec, AG · 2018
- Descendant · 4 generations on · 0 of its ownK243711 Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe…Wuxi Hisky Medical Technologies Co., Ltd. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K161112KARL STORZ Flexible Video-Neuro-Endoscope SystemKARL STORZ Endoscopy-America, Inc. · 2016 · cites it directly6descendants
- K180270Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies · 2018 · 2 generations on5descendants
- K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2020 · 3 generations on2descendants
- K181116ConvivoCarl Zeiss Meditec, AG · 2018 · 3 generations on1descendant
- K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002788 | Ksea Neuro-Fiberscope | KARL STORZ Endoscopy-America, Inc. | 2000 | — |
| +1 | K161112 | KARL STORZ Flexible Video-Neuro-Endoscope System | KARL STORZ Endoscopy-America, Inc. | 2016 | — |
| +2 | K180270 | Cellvizio 100 Series Systems with Confocal Miniprobes | Mauna Kea Technologies | 2018 | — |
| +3 | K191144 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2020 | — |
| +3 | K181116 | Convivo | Carl Zeiss Meditec, AG | 2018 | — |
| +4 | K243711 | Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging… | Wuxi Hisky Medical Technologies Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 27, 2019 | Class II | Z-1531-2020 | Error in labeling | During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E… |
| Aug 27, 2019 | Class II | Z-1530-2020 | Error in labeling | During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E… |
| Aug 27, 2019 | Class II | Z-1532-2020 | Error in labeling | During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E… |
| Feb 20, 2019 | Class II | Z-2425-2019 | Employee error | The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K161112 (KARL STORZ Endoscopy-America, Inc., 2016) has gone furthest, with 6 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.
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 | — |
https://510kreport.com/device/K002788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002788: Ksea Neuro-Fiberscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002788
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026