# K101734: Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera Handpiece; Visionscope Endoscopes

- Pathway: 510(k) (Traditional)
- Applicant: Visionscope Technologies, LLC
- Decided: Sep 8, 2010 after 79 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 K833587 (1983). 34 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072879: Innervue Diagnostic Scope System, Biomet Orthopedics, Inc. (2008) Summary page 1.
- K070266: 560 High Definition Camera System, Smith & Nephew, Inc. (2007) Summary page 1.
- K072675: Smith & Nephew Arthroscope, Smith & Nephew, Inc. (2007) Summary page 1.
- K082813: Stryker Led Lightsource, Stryker Corp. (2008) Summary page 1.
- K990354: Endosheath, Vision-Sciences, Inc. (1999) Summary page 1.
- K060777: Smith & Nephew Model 660HD Image Management System, Smith & Nephew, Inc. (2006) Summary page 1.

## Most influential descendants
- K153606: LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application (2016), 6 descendants of its own
- K190367: Smith & Nephew Tablet Application (2019), 3 descendants of its own
- K192876: INTELLIO Tablet Application (2020), 2 descendants of its own
- K203566: Tablet Application (2021), 1 descendant of its own
- K191177: LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head (2019), 1 descendant of its own

## Indications for use
The VisionScope High Definition Endoscopy Camera System is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination, visualization and capture of still and motion pictures of an interior cavity of the body through a natural or surgical opening. Examples of generic surgical use include imaging of articular cavities, body cavities, hollow organs and canals. Additionally, when used in conjunction with an appropriately indicated and FDA 5 10(k)-cleared endoscope and light source, the VisionScope High Definition Endoscopy Camera Control Unit and Camera Handpiece are indicated for use in arthroscopic and endoscopic surgical procedures to provide illumnination, visualization and capture of still and motion pictures of articular cavities, body cavities, hollow organs and canals.

Source page: https://510kreport.com/device/K101734
Methodology: https://510kreport.com/methodology