Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K243053 · 2025-06-20

ApplicantClaronav
Decision Date2025-06-20
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Navient Image Guided Navigation System (ENT) (955-NC-NC) is a medical device manufactured by Claronav. It received FDA 510(k) clearance on 2025-06-20 under approval number K243053. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Navient Image Guided Navigation System (ENT) (955-NC-NC)?

Navient Image Guided Navigation System (ENT) (955-NC-NC) is a medical device that received FDA 510(k) clearance on 2025-06-20. It is manufactured by Claronav. The 510(k) number is K243053.

When was Navient Image Guided Navigation System (ENT) (955-NC-NC) approved by the FDA?

Navient Image Guided Navigation System (ENT) (955-NC-NC) received FDA 510(k) clearance on 2025-06-20, under approval number K243053.

What company makes Navient Image Guided Navigation System (ENT) (955-NC-NC)?

Navient Image Guided Navigation System (ENT) (955-NC-NC) is manufactured by Claronav.

What is the FDA product code for Navient Image Guided Navigation System (ENT) (955-NC-NC)?

The FDA product code for Navient Image Guided Navigation System (ENT) (955-NC-NC) is PGW.

Related Clinical Trials

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 NCT07382674 Zesty Exercise System for Therapeutic Engagement RECRUITING NCT07607899 Virtual Reality for Pain and Well-Being in Older Adults NOT_YET_RECRUITING NCT06253858 Ultrasound (US) Guided External Ventricular Catheter Placement RECRUITING

Related PubMed Literature

PMID: 42184430 Navigation-guided endoscopic transcerebellar approach for cyst fenestration of a dorsal brainstem lesion: illustrative case. Journal of neurosurgery. Case lessons (2026) 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

K241327Navient Image Guide Navigation System (955-NC-NC), Cranial

Related Devices (Code: PGW)

K162176Fiagon Navigation SystemFiagon GmbH K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc. K161701CARTO ENT SystemBiosense Webster K161555KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc. K161940Guidewire 0.6 Single UseFiagon GmbH K153555EM ENT Navigated SuctionsMedtronic Navigation, 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.

↑