# K003710: Dyonics Vision 337 Autoclavable Camera Head Model 7209048; Dyonics Autoclavable Camera Coupler Model 7207905

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 2, 2001 after 63 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K914919 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972471: Digital 3-Chip Color Video Camera, Illuminators, Video Components and Accessories, Smith & Nephew, Inc. (1997) Summary page 4.
- K914919: Smith & Nephew Dyonics Laparoscopy System, Smith & Nephew Dyonics, Inc. (1992) Summary page 4.

## Indications for use
The Dyonics Vision 337 Autoclavable Camera Head and Camera Coupler are indicated for use in endoscopic surgical procedures to provide illumination and allow visualization of articular cavities, body cavities, hollow organs and canals when used in conjunction with an appropriately indicated endoscope. Additionally, the Dyonics Vision 337 Autoclavable Camera Head and Camera Coupler are indicated for use in endoscopic surgical procedures in the thoracic cavitity when used in conjunction with an appropriately indicated thoracoscope.

Source page: https://510kreport.com/device/K003710
Methodology: https://510kreport.com/methodology