# K081102: Vsu - Visionsense Stereoscopic Vision System

- Pathway: 510(k) (Traditional)
- Applicant: Visionsense, Ltd.
- Decided: May 29, 2008 after 42 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002431 (2000). 3 ancestors in all.
42 later devices descend from it; 3 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073279: VS-Visionsense Stereoscopic Vision System, Visionsense, Ltd. (2008) Summary page 2.
- K964281: Aesculap Angled Neuroendoscopes, Aesculap, Inc. (1997) Summary page 2.

## Most influential descendants
- K131434: VS3 Stereoscopic High Definition Vision System (2013), 38 descendants of its own
- K082355: Visionsense Stereoscopic Vision System (2008), 37 descendants of its own
- K141002: VS3 Stereoscopic High Definition Vision System (2014), 36 descendants of its own
- K152204: VS3-IR system (2015), 34 descendants of its own
- K162882: KARL STORZ ICG Imaging System (2017), 32 descendants of its own

## Recalls of this device
- Mar 21, 2011 · Not classified · Z-1192-2012: 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 an

## Indications for use
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.

Source page: https://510kreport.com/device/K081102
Methodology: https://510kreport.com/methodology