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FDA 510(k)

TruDi® Navigation System V3 (FG-2000-00)

K-Number: K231862 · 2023-07-21

ApplicantAcclarent, Inc.
Decision Date2023-07-21
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TruDi® Navigation System V3 (FG-2000-00) is a medical device manufactured by Acclarent, Inc.. It received FDA 510(k) clearance on 2023-07-21 under approval number K231862. 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 V3 (FG-2000-00)?

TruDi® Navigation System V3 (FG-2000-00) is a medical device that received FDA 510(k) clearance on 2023-07-21. It is manufactured by Acclarent, Inc.. The 510(k) number is K231862.

When was TruDi® Navigation System V3 (FG-2000-00) approved by the FDA?

TruDi® Navigation System V3 (FG-2000-00) received FDA 510(k) clearance on 2023-07-21, under approval number K231862.

What company makes TruDi® Navigation System V3 (FG-2000-00)?

TruDi® Navigation System V3 (FG-2000-00) is manufactured by Acclarent, Inc..

What is the FDA product code for TruDi® Navigation System V3 (FG-2000-00)?

The FDA product code for TruDi® Navigation System V3 (FG-2000-00) 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 NCT07271238 Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures RECRUITING NCT06895187 Catheter Ablation Using a Novel Navigation and Imaging System NOT_YET_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 Acclarent, Inc.

K161697Acclarent NavWire Sinus Navigation Guidewire K161698Relieva UltirraNav Sinus Balloon Catheter DEN150056Acclarent Aera Eustachian Tube Balloon Dilation System K153341Relieva Scout Multi-Sinus Dilation System K171687Relieva SpinPlus Nav Balloon Sinuplasty System K180948TruDi NAV Suction Instruments

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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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