Digital ClarusScope System; Digital NeuroPEN System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K240535 FDA 510(k)
- FDA Product Code
- HRX FDA 510(k)
- Models / Variants
- Digital ClarusScope System FDA 510(k)Digital NeuroPEN System FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.1100 FDA 510(k)
- Regulation Number
- 888.1100 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Digital ClarusScope System and Digital NeuroPEN System are single-use neurological endoscopes designed for real-time visual confirmation of ventricular catheter placement. These devices feature a 1.1 mm diameter endoscope with a CMOS camera at the distal tip for high-definition video capture and an integrated irrigation channel to maintain a clear line of sight during procedures.
The system includes a reusable Digital Control Module that processes the video signal from the endoscope and transmits it via HDMI to an external monitor. Supplied as sterile, single-use devices, they are intended for use in neurosurgical settings and have received FDA 510(k) clearance under the Orthopedic advisory committee. The devices are classified under product code HRX and are manufactured by Clarus Medical, LLC.
Frequently asked questions
What is the primary purpose of the Digital ClarusScope System and Digital NeuroPEN System in a neurosurgical procedure?
These devices are designed specifically for real-time visual confirmation of ventricular catheter placement during neurosurgical procedures. The 1.1 mm diameter endoscope with a built-in CMOS camera provides high-definition video imaging, while the integrated irrigation channel helps maintain a clear field of view by flushing away obstructions. This ensures accurate and precise catheter positioning.
Are the Digital ClarusScope System and Digital NeuroPEN System reusable or single-use, and how does this affect their use?
The endoscope components of both systems are sterile, single-use devices, meaning they are intended for one-time use per patient to ensure sterility and safety. The reusable Digital Control Module, however, processes the video signal and can be used repeatedly across multiple procedures, reducing overall costs while maintaining performance. This design aligns with best practices for minimizing infection risks in sterile environments.
How do I connect and use the Digital ClarusScope System or Digital NeuroPEN System with an external monitor?
The system includes a reusable Digital Control Module that captures the video signal from the endoscope and transmits it via HDMI to an external monitor. This allows clinicians to view the high-definition imaging in real time on their existing display setup, enabling precise visualization of catheter placement without requiring additional hardware beyond the monitor itself.
What sizes or models are available for the Digital ClarusScope System and Digital NeuroPEN System?
Both systems feature a single endoscope size with a 1.1 mm diameter, which is standardized for flexibility in neurosurgical procedures. While the core endoscope dimensions remain consistent, the systems may offer variations in accessories or control module configurations—though the primary imaging and irrigation functionality is uniform across both the ClarusScope and NeuroPEN models.
How should the Digital ClarusScope System or Digital NeuroPEN System be stored to maintain its performance and sterility?
Since the endoscope components are sterile, single-use, they should be stored in their original packaging until immediately before use, following the manufacturer’s instructions to preserve sterility. The reusable Digital Control Module should be cleaned and disinfected according to the provided guidelines after each use to ensure optimal functionality and longevity. Proper storage conditions (e.g., dry, protected from physical damage) are also recommended for both components.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Neuro 2024 - Clarus Medical LLC, Digital ClarusScope System; Digital NeuroPEN System (K240535) — FDA 510 ..., Digital ClarusScope System, Digital NeuroPEN System (K223615) — FDA 510 ..., Digital ClarusScope System, Digital NeuroPEN System (K223615) — FDA 510 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240535 | Class II | Active |
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Manufacturer
- Manufacturer
- Clarus Medical, Llc
Sources (1)
- FDA 510(k) K240535 24 fields · synced Sep 19, 2026