# K141002: VS3 Stereoscopic High Definition Vision System

- Pathway: 510(k) (Traditional)
- Applicant: Visionsense, Ltd.
- Decided: Jun 26, 2014 after 69 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K923160 (1992). 16 ancestors in all.
36 later devices descend from it; 2 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131434: VS3 Stereoscopic High Definition Vision System, Visionsense, Ltd. (2013) Summary page 1.
- K082355: Visionsense Stereoscopic Vision System, Visionsense, Ltd. (2008) Summary page 1.
- K983142: Ksea C-Mount Arthroscopes, Karl Storz Endoscopy (1998) Summary page 1.

## Most influential descendants
- K152204: VS3-IR system (2015), 34 descendants of its own
- K162882: KARL STORZ ICG Imaging System (2017), 32 descendants of its own
- K171238: KARL STORZ ICG Imaging System (2017), 31 descendants of its own
- K180146: KARL STORZ ICG Imaging System (2018), 30 descendants of its own
- K211202: 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes (2021), 19 descendants of its own

## Indications for use
The VS3-OT system is intended for viewing internal surgical sites during general surgical procedures, visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and focraminotomny, and shoulder and knee arthroscopic procedures.

Source page: https://510kreport.com/device/K141002
Methodology: https://510kreport.com/methodology