# K070266: 560 High Definition Camera System

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 22, 2007 after 24 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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: 1 generation back to K031379 (2003). 1 ancestor in all.
9 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031379: Dyonics Vision 325Z DV3-CCD Hermes Ready Camera System, Model 7209531, Smith & Nephew, Inc. (2003) Summary page 2.

## Most influential descendants
- K101734: Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera Handpiece; Visionscope Endoscopes (2010), 7 descendants of its own
- 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

## Recalls of this device
- Mar 29, 2012 · Not classified · Z-1479-2012: May experience intermittent loss of video due to a defective board component

## Indications for use
The Smith & Nephew HD Camera System is indicated for use in endoscopic surgical procedures to allow visualization of the articular cavities, body cavities, hollow organs and canals when used with an appropriately indicated endoscope, Additionally, when used in conjunction with a Smith & Nephew light source and light cable the Smith & Nephew HD Camera System is indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope.

Source page: https://510kreport.com/device/K070266
Methodology: https://510kreport.com/methodology