510(k) · Cleared
Recalled · 2011Vsu - Visionsense Stereoscopic Vision System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visionsense, Ltd. · GWG Endoscope, Neurological
Cleared on May 29, 2008 as substantially equivalent to K073279 (Visionsense, Ltd., 2008) and 1 other predicate after a 42-day review. Its family tree reaches back 2 generations to 2000. 42 later devices descend from it. It has been recalled once.
- Decided
- May 29, 2008
- Review
- 42 days
- Class
- Class II
- Product code
- GWG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002431 (2000). 3 ancestors in all, the oldest K964281 (1997). 42 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK002431 Elran 01 SystemEnvision Advanced Medical System, Ltd. · 2000
- 1 generation backK073279 VS-Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008
- This deviceK081102 Vsu - Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008
- Descendant · cites it directly · 38 of its ownK131434 VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2013
- Descendant · cites it directly · 37 of its ownK082355 Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008
- Descendant · 2 generations on · 36 of its ownK141002 VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2014
- Descendant · 2 generations on · 34 of its ownK152204 VS3-IR systemVisionsense, Ltd. · 2015
- Descendant · 3 generations on · 32 of its ownK162882 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K131434VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2013 · cites it directly38descendants
- K082355Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008 · cites it directly37descendants
- K141002VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2014 · 2 generations on36descendants
- K152204VS3-IR systemVisionsense, Ltd. · 2015 · 2 generations on34descendants
- K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017 · 3 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002431 | Elran 01 System | Envision Advanced Medical System, Ltd. | 2000 | — |
| −1 | K073279 | VS-Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | — |
| 0 (this device) | K081102 | Vsu - Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | — |
| +1 | K131434 | VS3 Stereoscopic High Definition Vision System | Visionsense, Ltd. | 2013 | — |
| +1 | K082355 | Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | — |
| +2 | K141002 | VS3 Stereoscopic High Definition Vision System | Visionsense, Ltd. | 2014 | — |
| +2 | K152204 | VS3-IR system | Visionsense, Ltd. | 2015 | — |
| +3 | K162882 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K073279 | VS-Visionsense Stereoscopic Vision SystemSummary page 2…Neurology Product Code: GWG Device Class: Class II Predicate Devices 510(k) number Trade or propriety name Manufacturer K073279 VS,, (General Surgery) Visionsense Ltd. K964281 Aesculap Angled Neuroendoscopes… | 2008 |
| * | K964281 | Aesculap Angled NeuroendoscopesSummary page 2…10(k) number Trade or propriety name Manufacturer K073279 VS,, (General Surgery) Visionsense Ltd. K964281 Aesculap Angled Neuroendoscopes Aesculap Inc. Intended Use/Indications for Use The VS,, system is intende… | 1997 |
What descends from it? (42)
See all 423 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 |
|---|---|---|---|---|
| Mar 21, 2011 | Not classified | Z-1192-2012 | Nonconforming Material/Component | A complaint was received and a unit returned that exhibited the metal and glass shaft window becoming dislodged during scope cleaning. Additionally, during in-process visual inspection of the metal and glass shaft window sub-assembly from… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 7.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K131434 (Visionsense, Ltd., 2013) has gone furthest, with 38 descendants of its own.
- 3 other devices also cite its predicate K073279.
How does its category compare?
All GWG devicesGWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 VS,, system is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081102: Vsu - Visionsense Stereoscopic Vision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081102
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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