Cleared Traditional

TruDi Navigation System (K192397) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192397 · Biosense Webster · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2020
Decision
149d
Days
Class 2
Risk

K192397 is an FDA 510(k) clearance for the TruDi Navigation System. Classified as Ear, Nose, And Throat Stereotaxic Instrument (product code PGW), Class II - Special Controls.

Submitted by Biosense Webster (Irvin, US). The FDA issued a Cleared decision on January 30, 2020 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 882.4560 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Biosense Webster devices

Submission Details

510(k) Number K192397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2019
Decision Date January 30, 2020
Days to Decision 149 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 89d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PGW Ear, Nose, And Throat Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Intended As An Aid For Precisely Locating A Surgical Instrument Within Anatomical Structures In Either Open Or Percutaneous Procedures For Any Medical Condition In Which A Reference To A Rigid Anatomical Structure In The Field Of Ent Surgery Can Be Identified Relative To A Ct- Or Mr-based Model Or Digitized Landmarks Of The Anatomy.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Consultant

Acclarent, Inc.
David Locke

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PGW Ear, Nose, And Throat Stereotaxic Instrument

All 36
Devices cleared under the same product code (PGW) and FDA review panel - the closest regulatory comparables to K192397.
Cube 4D Navigation System, VirtuEye Pro
K261540 · Fiagon GmbH · Jun 2026
Stealth AXiS™ ENT clinical application
K253395 · Medtronic Navigation, Inc. · Mar 2026
Navient Image Guided Navigation System (ENT) (955-NC-NC)
K243053 · Claronav · Jun 2025
TruDi® Navigation System V3 (FG-2000-00)
K231862 · Acclarent, Inc. · Jul 2023
ENT EM
K223734 · Brainlab AG · Apr 2023
TruDi Shaver Blade
K221037 · Acclarent, Inc. · Jul 2022