510(k) · Cleared
ClearedNeuro-Endoscope System by Hopf, Existing of: Endoscopes, Sheaths, Working Elements, Bipolar and Unipolar Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · GWG Endoscope, Neurological
Cleared on Jul 29, 2004 as substantially equivalent to K970162 (Richard Wolf Medical Instruments Corp., 1997) after a 409-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Jul 29, 2004
- Review
- 409 days
- Class
- Class II
- Product code
- GWG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K941239 (1994). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941239 | Aesculap Neuroendoscope | Aesculap, Inc. | 1994 | — |
| −1 | K970162 | Neurological Endoscope | Richard Wolf Medical Instruments Corp. | 1997 | — |
| 0 (this device) | K031858 | Neuro-Endoscope System by Hopf, Existing of: Endoscopes, Sheaths, Working… | Richard Wolf Medical Instruments Corp. | 2004 | — |
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 |
|---|---|---|---|
| * | K970162 | Neurological EndoscopeSummary page 1…Information on devices to which substantial equivalence is claimed: 510(k) Number Trade or proprietary or model name Manufacturer iK970162 i Neurological Endoscope Set i Richard Wolf 1.0 Description The submitted neuroendo… | 1997 |
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K970162.
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 Minature Neuro-Endoscope System by Hopf allows visual observation of the operating site while using working channels, supply and drain channels. They are used for diagnosis and therapy in neurosurgery, in connection with endoscopic accessories, during intracranial procedures.
The EANS System (Endoscopic Assisted Neuro Surgery) allows a visualization of cerebral structures not visible through the microscope and at the same time offers the option of supplying and draining irrigation fluid, for examination and diagnosis of microsurgical brain operation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031858: Neuro-Endoscope System by Hopf, Existing of: Endoscopes, Sheaths, Working Elements, Bipolar and Unipolar Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031858
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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