# K223615: Digital ClarusScope System, Digital NeuroPEN System

- Pathway: 510(k) (Traditional)
- Applicant: Clarus Medical, LLC
- Decided: Nov 21, 2023 after 351 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945633 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945633: Neuro Channel Endoscope Model 2232, Clarus Medical Systems, Inc. (1995) Summary page 5.

## Indications for use
The Digital ClarusScope System and Digital NeuroPEN System are intended for use in neurosurgery, endoscopic neurosurgery, and ventriculoscopy for visualization of ventricles and structures within the brain during neurological surgical procedures, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.

Source page: https://510kreport.com/device/K223615
Methodology: https://510kreport.com/methodology