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FDA 510(k)

Navient Image Guide Navigation System (955-NC-NC), Cranial

K-Number: K241327 · 2025-02-05

ApplicantClaronav
Decision Date2025-02-05
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Navient Image Guide Navigation System (955-NC-NC), Cranial is a medical device manufactured by Claronav. It received FDA 510(k) clearance on 2025-02-05 under approval number K241327. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Navient Image Guide Navigation System (955-NC-NC), Cranial?

Navient Image Guide Navigation System (955-NC-NC), Cranial is a medical device that received FDA 510(k) clearance on 2025-02-05. It is manufactured by Claronav. The 510(k) number is K241327.

When was Navient Image Guide Navigation System (955-NC-NC), Cranial approved by the FDA?

Navient Image Guide Navigation System (955-NC-NC), Cranial received FDA 510(k) clearance on 2025-02-05, under approval number K241327.

What company makes Navient Image Guide Navigation System (955-NC-NC), Cranial?

Navient Image Guide Navigation System (955-NC-NC), Cranial is manufactured by Claronav.

What is the FDA product code for Navient Image Guide Navigation System (955-NC-NC), Cranial?

The FDA product code for Navient Image Guide Navigation System (955-NC-NC), Cranial is HAW.

Related Clinical Trials

NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT06253858 Ultrasound (US) Guided External Ventricular Catheter Placement RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Claronav

K243053Navient Image Guided Navigation System (ENT) (955-NC-NC)

Related Devices (Code: HAW)

K162604Cranial Reducing TubesMedtronic Navigation, Inc. K160811CRW STEREOTACTIC SYSTEMIntegra LifeSciences Corporation K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. K152764EXACTECH GPSBlue Ortho K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc. K151156Fiagon Navigation SystemFiagon GmbH

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.

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