# K203526: C Scope Visualization System

- Pathway: 510(k) (Traditional)
- Applicant: Cit Ortho
- Decided: Jan 12, 2021 after 41 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K833587 (1983). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143705: NeedleCam HD Visualization System, Biovision Technologies, LLC (2015) Summary page 4.

## Recalls of this device
- Feb 11, 2025 · Class II · Z-1453-2025: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to pati
- Apr 8, 2024 · Class II · Z-3053-2024: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to pat

## Indications for use
The C Scope Visualization System is indicated to be used by a trained physician to provide illumination and visualization in arthroscopic procedures of an interior cavity of the body through a surgical opening.

Source page: https://510kreport.com/device/K203526
Methodology: https://510kreport.com/methodology