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FDA 510(k)

X-Guide® Surgical Navigation System

K-Number: K200662 · 2020-05-21

ApplicantX-Nav Technologies, LLC
Decision Date2020-05-21
Product CodePLV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

X-Guide® Surgical Navigation System is a medical device manufactured by X-Nav Technologies, LLC. It received FDA 510(k) clearance on 2020-05-21 under approval number K200662. The device is classified under product code PLV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-Guide® Surgical Navigation System?

X-Guide® Surgical Navigation System is a medical device that received FDA 510(k) clearance on 2020-05-21. It is manufactured by X-Nav Technologies, LLC. The 510(k) number is K200662.

When was X-Guide® Surgical Navigation System approved by the FDA?

X-Guide® Surgical Navigation System received FDA 510(k) clearance on 2020-05-21, under approval number K200662.

What company makes X-Guide® Surgical Navigation System?

X-Guide® Surgical Navigation System is manufactured by X-Nav Technologies, LLC.

What is the FDA product code for X-Guide® Surgical Navigation System?

The FDA product code for X-Guide® Surgical Navigation System is PLV.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42184430 Navigation-guided endoscopic transcerebellar approach for cyst fenestration of a dorsal brainstem lesion: illustrative case. Journal of neurosurgery. Case lessons (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) 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 X-Nav Technologies, LLC

K192579X-Guide Surgical Navigation System K211701X-Guide® Surgical Navigation System K232148X-Guide Surgical Navigation System

Related Devices (Code: PLV)

K161399Neocis Guidance SystemNeocis, Inc. K161406NavidentClaronav, Inc. K182776Neocis Guidance SystemNeocis, Inc. K173402Neocis Guidance System (NGS) with Chairside SplintNeocis, Inc. K191363Neocis Planning Software Application (NPSA) for 3rd Party PCsNeocis, Inc. K191605Neocis Guidance System (NGS)Neocis, 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.

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