510(k) · Cleared
ClearedDigital ClarusScope System, Digital NeuroPEN System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clarus Medical, LLC · GWG Endoscope, Neurological
Cleared on Nov 21, 2023 as substantially equivalent to K945633 (Clarus Medical Systems, Inc., 1995) after a 351-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Nov 21, 2023
- Review
- 351 days
- Class
- Class II
- Product code
- GWG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945633 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK945633 Neuro Channel Endoscope Model 2232Clarus Medical Systems, Inc. · 1995 · Recalled
- This deviceK223615 Digital ClarusScope System, Digital NeuroPEN SystemClarus Medical, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945633 | Neuro Channel Endoscope Model 2232 | Clarus Medical Systems, Inc. | 1995 | 1 |
| 0 (this device) | K223615 | Digital ClarusScope System, Digital NeuroPEN System | Clarus Medical, LLC | 2023 | — |
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 |
|---|---|---|---|
| * | K945633 | Neuro Channel Endoscope Model 2232Summary page 5…: Neurological endoscope Class: II C. Predicate Device: 510(k) Number Description K945633 Clarus Model 2232 Neuro Channel Scope D. Reference Devices: 510(k) Number Description… | 1995 |
| † | K942249 | Clarus Neuropen Model 2120 | 1994 |
| † | K161112 | KARL STORZ Flexible Video-Neuro-Endoscope System | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has a recall.
How does its category compare?
All GWG devicesGWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Digital ClarusScope System and Digital NeuroPEN System are intended for use in neurosurgery, endoscopic neurosurgery, and ventriculoscopy for visualization of ventricles and structures within the brain during neurological surgical procedures, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223615: Digital ClarusScope System, Digital NeuroPEN System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223615
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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