Cleared Traditional

TruDi NAV Wire

K190532 · Acclarent, Inc. · Ear, Nose, Throat

May 2019

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K190532 is an FDA 510(k) clearance for the TruDi NAV Wire, a Ear, Nose, And Throat Stereotaxic Instrument (Class II — Special Controls, product code PGW), submitted by Acclarent, Inc. (Irvin, US). The FDA issued a Cleared decision on May 3, 2019, 60 days after receiving the submission on March 4, 2019. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K190532 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	PGW — Ear, Nose, And Throat Stereotaxic Instrument
Device Class	Class II — 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.