510(k) · Cleared
ClearedAesculap Angled Neuroendoscopes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GWG Endoscope, Neurological
Cleared on Apr 21, 1997 after a 175-day review. The FDA summary names its predicate without a number. 43 later devices descend from it.
- Decided
- Apr 21, 1997
- Review
- 175 days
- Class
- Class II
- Product code
- GWG
- Recalls
- None
- Predicates
- 0
43 later devices descend from it, 1 citing it directly.
- This deviceK964281 Aesculap Angled NeuroendoscopesAesculap, Inc. · 1997
- Descendant · cites it directly · 42 of its ownK081102 Vsu - Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008 · Recalled
- Descendant · 2 generations on · 38 of its ownK131434 VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2013
- Descendant · 2 generations on · 37 of its ownK082355 Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008
- Descendant · 3 generations on · 36 of its ownK141002 VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2014
- Descendant · 3 generations on · 34 of its ownK152204 VS3-IR systemVisionsense, Ltd. · 2015
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K081102Vsu - Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008 · cites it directly42descendants
- K131434VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2013 · 2 generations on38descendants
- K082355Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008 · 2 generations on37descendants
- K141002VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2014 · 3 generations on36descendants
- K152204VS3-IR systemVisionsense, Ltd. · 2015 · 3 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964281 | Aesculap Angled Neuroendoscopes | Aesculap, Inc. | 1997 | — |
| +1 | K081102 | Vsu - Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | 1 |
| +2 | K131434 | VS3 Stereoscopic High Definition Vision System | Visionsense, Ltd. | 2013 | — |
| +2 | K082355 | Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | — |
| +3 | K141002 | VS3 Stereoscopic High Definition Vision System | Visionsense, Ltd. | 2014 | — |
| +3 | K152204 | VS3-IR system | Visionsense, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 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? (3)
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 |
|---|---|---|---|
| * | — | Aesculap Neuroendoscope Named without a submission number | |
| * | — | Aesculap Endoscopes Named without a submission number | |
| * | — | Codman Neuroendoscopes Named without a submission number |
What descends from it? (43)
See all 431 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081102 | Vsu - Visionsense Stereoscopic Vision System | 2008 | 42 |
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, K081102 (Visionsense, Ltd., 2008) has gone furthest, with 42 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?
Aesculap’s Angled Neuroendoscopes are intended for use in visualization of ventricles and structures within the brain.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964281: Aesculap Angled Neuroendoscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964281
Report an extraction error
Are you the manufacturer?
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