# K252790: Digital ClarusScope System and Digital NeuroPEN System

- Pathway: 510(k) (Traditional)
- Applicant: Clarus Medical, LLC
- Decided: May 26, 2026 after 266 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: 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 5.

## Indications for use
The Digital ClarusScope System and Digital NeuroPEN System are intended for accessing and visualizing the interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures on the ankle, elbow, wrist, and spine.

Source page: https://510kreport.com/device/K252790
Methodology: https://510kreport.com/methodology