# K153548: VS3 Stereoscopic High Definition Vision System

- Pathway: 510(k) (Traditional)
- Applicant: Visionsense, Ltd.
- Decided: Feb 22, 2016 after 73 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: 6 generations back to K923160 (1992). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141002: VS3 Stereoscopic High Definition Vision System, Visionsense, Ltd. (2014) Summary page 4.

## Indications for use
The 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 foraminotomy, and shoulder and large joint arthroscopic procedures.

Source page: https://510kreport.com/device/K153548
Methodology: https://510kreport.com/methodology