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FDA 510(k)

X-Guide® Surgical Navigation System

K-Number: K211701 · 2022-02-01

ApplicantX-Nav Technologies, LLC
Decision Date2022-02-01
Product CodeQRY
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 2022-02-01 under approval number K211701. The device is classified under product code QRY. 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 2022-02-01. It is manufactured by X-Nav Technologies, LLC. The 510(k) number is K211701.

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

X-Guide® Surgical Navigation System received FDA 510(k) clearance on 2022-02-01, under approval number K211701.

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 QRY.

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

K200662X-Guide® Surgical Navigation System K192579X-Guide Surgical Navigation System K232148X-Guide Surgical Navigation System

Related Devices (Code: QRY)

K222750Yomi Robotic SystemNeocis, Inc. K222049Yomi Robotic SystemNeocis, Inc. K232148X-Guide Surgical Navigation SystemX-Nav Technologies, LLC

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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