# K240535: Digital ClarusScope System; Digital NeuroPEN System

- Pathway: 510(k) (Traditional)
- Applicant: Clarus Medical, LLC
- Decided: Apr 25, 2024 after 59 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: 2 generations back to K941188 (1995). 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)
- K974579: Percscope Model 2600, Clarus Medical Systems, Inc. (1998) Summary page 5.

## Indications for use
The Digital ClarusScope System and Digital NeuroPEN System are intended for accessing and visualizing the spinal nerve roots, foramina, intervertebral disc, and surrounding tissues of the spine during discectomy procedures, bone and osteophyte removal, and procedures associated with ruptured or herniated discs.

Source page: https://510kreport.com/device/K240535
Methodology: https://510kreport.com/methodology