Cleared Traditional

K190532 - TruDi NAV Wire

K190532 is the FDA 510(k) clearance for TruDi NAV Wire by Acclarent, Inc.. It is a Class 2 Ear, Nose, Throat device (product code PGW) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K190532 · Acclarent, Inc. · Ear, Nose, Throat device
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May 2019
Decision
60d
Days
Class 2
Risk

K190532 is an FDA 510(k) clearance for the TruDi NAV Wire. Classified as Ear, Nose, And Throat Stereotaxic Instrument (product code PGW), Class II - Special Controls.

Submitted by Acclarent, Inc. (Irvin, US). The FDA issued a Cleared decision on May 3, 2019 after a review of 60 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Acclarent, Inc. devices

Submission Details

510(k) Number K190532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2019
Decision Date May 03, 2019
Days to Decision 60 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
29d faster than avg
Panel avg: 89d · This submission: 60d
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 Peers - PGW Ear, Nose, And Throat Stereotaxic Instrument

All 24
Devices cleared under the same product code (PGW) and FDA review panel - the closest regulatory comparables to K190532.
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TruDi Navigation System
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TruDi NAV Suction Instruments
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K170018 · Medtronic Navigation, Inc. · May 2017