Digital ClarusScope System, Digital NeuroPEN System
K-Number: K223615 · 2023-11-21
ApplicantClarus Medical, LLC
Decision Date2023-11-21
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Digital ClarusScope System, Digital NeuroPEN System is a medical device manufactured by Clarus Medical, LLC. It received FDA 510(k) clearance on 2023-11-21 under approval number K223615. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Digital ClarusScope System, Digital NeuroPEN System?
Digital ClarusScope System, Digital NeuroPEN System is a medical device that received FDA 510(k) clearance on 2023-11-21. It is manufactured by Clarus Medical, LLC. The 510(k) number is K223615.
When was Digital ClarusScope System, Digital NeuroPEN System approved by the FDA?
Digital ClarusScope System, Digital NeuroPEN System received FDA 510(k) clearance on 2023-11-21, under approval number K223615.
What company makes Digital ClarusScope System, Digital NeuroPEN System?
Digital ClarusScope System, Digital NeuroPEN System is manufactured by Clarus Medical, LLC.
What is the FDA product code for Digital ClarusScope System, Digital NeuroPEN System?
The FDA product code for Digital ClarusScope System, Digital NeuroPEN System is GWG.
Related Clinical Trials
NCT07301385
Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study
ACTIVE_NOT_RECRUITING
NCT07557147
Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor
NOT_YET_RECRUITING
NCT07586163
Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency
ACTIVE_NOT_RECRUITING
NCT07578142
AcceXible Speech-Based Screening for Depression and Anxiety in University Students (UAQ, Mexico)
NOT_YET_RECRUITING
NCT07578155
Validation of Accexible Screening and Self-Administered Activities for Emotional Well-Being in a University Hospital (UaDEC)
COMPLETED
NCT07541365
Feasibility and Acceptability of Wearable Sensors and ePROs in Early Phase Clinical Trials
NOT_YET_RECRUITING
Related PubMed Literature
PMID: 41734979
Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review.
Yonsei medical journal (2026)
PMID: 41491965
From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum.
Current opinion in nephrology and hypertension (2026)
PMID: 40942702
Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health.
Sensors (Basel, Switzerland) (2025)
PMID: 40845310
Should Digital Interventions for HIV Self-Testing Be Regulated with World Health Organization Prequalification?
JMIR mHealth and uHealth (2025)
Other Devices by Clarus Medical, LLC
Related Devices (Code: GWG)
K161112KARL STORZ Flexible Video-Neuro-Endoscope SystemKARL STORZ Endoscopy-America, Inc.
K152699Apollo SystemPenumbra, Inc.
K170667QEVO System with KINEVO 900Carl Zeiss Meditec, AG
K171332Artemis Neuro Evacuation DevicePenumbra, Inc.
K170462KARL STORZ ShuntScopeKARL STORZ Endoscopy-America, Inc.
K162880TIPCAM 1S 3D SystemKarl Storz Endoscopy America, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.