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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 the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2023-07-21 under 510(k) 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. The listed applicant is Acclarent, Inc.. The 510(k) number is K231862.

When did TruDi® Navigation System V3 (FG-2000-00) receive FDA 510(k) clearance?

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

Who is the listed applicant for TruDi® Navigation System V3 (FG-2000-00)?

The FDA 510(k) record lists Acclarent, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Acclarent, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemK230742ACCLARENT AERA Eustachian Tube Dilation SystemK221037TruDi Shaver BladeK201115Next Generation Balloon Dilation SystemK201174TruDi CuretteK193453TruDi Probe

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Related Devices (Code: PGW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbHK253395Stealth AXiS™ ENT clinical applicationMedtronic Navigation, Inc.K243053Navient Image Guided Navigation System (ENT) (955-NC-NC)ClaronavK223734ENT EMBrainlab AGK221037TruDi Shaver BladeAcclarent, Inc.K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation UnitStryker Corporation

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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