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FDA 510(k)

TruDi Navigation System

K-Number: K192397 · 2020-01-30

ApplicantBiosense Webster
Decision Date2020-01-30
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TruDi Navigation System is a medical device manufactured by Biosense Webster. It received FDA 510(k) clearance on 2020-01-30 under approval number K192397. 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 TruDi Navigation System?

TruDi Navigation System is a medical device that received FDA 510(k) clearance on 2020-01-30. It is manufactured by Biosense Webster. The 510(k) number is K192397.

When was TruDi Navigation System approved by the FDA?

TruDi Navigation System received FDA 510(k) clearance on 2020-01-30, under approval number K192397.

What company makes TruDi Navigation System?

TruDi Navigation System is manufactured by Biosense Webster.

What is the FDA product code for TruDi Navigation System?

The FDA product code for TruDi Navigation System is PGW.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT04750798 An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias RECRUITING NCT07271238 Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures 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 Biosense Webster

K161701CARTO ENT System

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.

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