510(k) · Cleared
ClearedVS3 Stereoscopic High Definition 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 Jul 16, 2013 as substantially equivalent to K081102 (Visionsense, Ltd., 2008) and 1 other predicate after a 60-day review. Its family tree reaches back 3 generations to 2000. 38 later devices descend from it.
- Decided
- Jul 16, 2013
- Review
- 60 days
- Class
- Class II
- Product code
- GWG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002431 (2000). 5 ancestors in all, the oldest K964281 (1997). 38 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK002431 Elran 01 SystemEnvision Advanced Medical System, Ltd. · 2000
- 2 generations backK073279 VS-Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008
- 1 generation backK081102 Vsu - Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008 · Recalled
- This deviceK131434 VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2013
- Descendant · cites it directly · 36 of its ownK141002 VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2014
- Descendant · cites it directly · 34 of its ownK152204 VS3-IR systemVisionsense, Ltd. · 2015
- Descendant · 2 generations on · 32 of its ownK162882 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
- Descendant · 3 generations on · 31 of its ownK171238 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
- Descendant · 3 generations on · 30 of its ownK180146 KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc. · 2018
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K141002VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2014 · cites it directly36descendants
- K152204VS3-IR systemVisionsense, Ltd. · 2015 · cites it directly34descendants
- K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017 · 2 generations on32descendants
- K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017 · 3 generations on31descendants
- K180146KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc. · 2018 · 3 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002431 | Elran 01 System | Envision Advanced Medical System, Ltd. | 2000 | — |
| −2 | K073279 | VS-Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | — |
| −1 | K081102 | Vsu - Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | 1 |
| 0 (this device) | K131434 | VS3 Stereoscopic High Definition Vision System | Visionsense, Ltd. | 2013 | — |
| +1 | K141002 | VS3 Stereoscopic High Definition Vision System | Visionsense, Ltd. | 2014 | — |
| +1 | K152204 | VS3-IR system | Visionsense, Ltd. | 2015 | — |
| +2 | K162882 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017 | — |
| +3 | K171238 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017 | — |
| +3 | K180146 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy America, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 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 |
|---|---|---|---|
| * | K081102 | Vsu - Visionsense Stereoscopic Vision SystemSummary page 1…scope, Neurological Review Panel: Neurology Product Code: GWG Device Class: Class 11 Regulation: 21 C.F.R. §882.1480 Predicate Device Information Visionsense Ltd VS11 (K081102) Visionsense Ltd V53 (K(123467) Intended Use/indications for Use The V53 Stereoscopic High Definition Vision System. Model V53-… | 2008 |
| * | K123467 | VS3Summary page 3…VS3-NE VS11 System (K081102) V53 for General Surgery (subectdevce)(prmar prdicte) (K1 23467) (secondary (rimay pedicte)predicate)… | 2013 |
What descends from it? (38)
See all 383 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)
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 13 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K141002 (Visionsense, Ltd., 2014) has gone furthest, with 36 descendants of its own.
- 2 other devices also cite its predicate K081102.
How does its category compare?
All GWG devicesGWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
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/K131434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131434: VS3 Stereoscopic High Definition 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/K131434
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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