Digital ClarusScope System and Digital NeuroPEN System
Device Facts
| Record ID | K252790 |
|---|---|
| Device Name | Digital ClarusScope System and Digital NeuroPEN System |
| Applicant | Clarus Medical, LLC |
| Product Code | HRX · Orthopedic |
| Decision Date | May 26, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.1100 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.
