# K043395: Smith & Nephew Videoarthroscope

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 12, 2005 after 33 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: 3 generations back to K833587 (1983). 13 ancestors in all.
32 later devices descend from it; 5 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971253: Various Arthroscopes, Endoscopic Blades, Manual Instruments, Smith & Nephew, Inc. (1997) Summary page 1.

## Most influential descendants
- K072879: Innervue Diagnostic Scope System (2008), 30 descendants of its own
- K082293: Surgview Integrated Visualization System (2008), 21 descendants of its own
- K093717: C-Mor Visualization Device (2010), 16 descendants of its own
- K072675: Smith & Nephew Arthroscope (2007), 8 descendants of its own
- K141119: Camera Enabled Probe (2014), 7 descendants of its own

## Indications for use
The Smith & Nephew VideoArthroscopes/ENT Endoscopes is indicated to provide illumination and visualization in diagnostic and operative arthroscopic procedures, endoscopic examination and treatment of the nasal cavities and nasal pharynx. In addition, the Smith & Nephew 4 mm diameter rigid VideoArthroscopes/ENT Endoscopes are indicated to provide illumination and visualization in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate.

Source page: https://510kreport.com/device/K043395
Methodology: https://510kreport.com/methodology