510(k) · Cleared
ClearedKsea Neuroendoscopes and Accessories
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 Jun 26, 2002 after an 86-day review. The FDA summary names no predicate by number. 31 later devices descend from it.
- Decided
- Jun 26, 2002
- Review
- 86 days
- Class
- Class II
- Product code
- GWG
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 1 citing it directly.
- This deviceK021050 Ksea Neuroendoscopes and AccessoriesKARL STORZ Endoscopy-America, Inc. · 2002
- Descendant · cites it directly · 30 of its ownK180146 KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc. · 2018
- Descendant · 2 generations on · 19 of its ownK211202 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight…Stryker · 2021
- Descendant · 3 generations on · 14 of its ownK214046 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM…Stryker · 2022
- Descendant · 4 generations on · 10 of its ownK221611 780 nm L11 LED Light Source with AIMStryker · 2022
- Descendant · 4 generations on · 8 of its ownK230216 1688 4K Camera Control Unit with Advanced Imaging Modality…Stryker · 2023
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K180146KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc. · 2018 · cites it directly30descendants
- K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker · 2021 · 2 generations on19descendants
- K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableStryker · 2022 · 3 generations on14descendants
- K221611780 nm L11 LED Light Source with AIMStryker · 2022 · 4 generations on10descendants
- K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)Stryker · 2023 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021050 | Ksea Neuroendoscopes and Accessories | KARL STORZ Endoscopy-America, Inc. | 2002 | — |
| +1 | K180146 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy America, Inc. | 2018 | — |
| +2 | K211202 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable… | Stryker | 2021 | — |
| +3 | K214046 | 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and… | Stryker | 2022 | — |
| +4 | K221611 | 780 nm L11 LED Light Source with AIM | Stryker | 2022 | — |
| +4 | K230216 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) | Stryker | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 6 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 8 | 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?
The FDA summary names no predicate by number.
What descends from it? (31)
See all 311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180146 | KARL STORZ ICG Imaging System | 2018 | 30 |
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?
- Of its descendants, K180146 (Karl Storz Endoscopy America, Inc., 2018) has gone furthest, with 30 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 | — |
What is it indicated for?
The Neuroendoscope Set is intended for use by qualified surgeons in endoscopic pituitary surgery.
ThNeuroendoscopes is intended for viewing the sella and pituitary gland in endoscopic pituitary surgery.
The Sheath is intended to be used to protect the Neuroendoscope and provides irrigation during the endoscopic procedures.
The KSEA Suction Tube is intended to remove blood, fluid, excised tissue, and debris from the operation site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021050 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021050: Ksea Neuroendoscopes and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021050
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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