Cleared Traditional

TruDi Probe

K193453 · Acclarent, Inc. · Ear, Nose, Throat

Mar 2020

Decision

101d

Days

Class 2

Risk

About This 510(k) Submission

K193453 is an FDA 510(k) clearance for the TruDi Probe, a Ear, Nose, And Throat Stereotaxic Instrument (Class II — Special Controls, product code PGW), submitted by Acclarent, Inc. (Irvine, US). The FDA issued a Cleared decision on March 23, 2020, 101 days after receiving the submission on December 13, 2019. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K193453 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2019
Decision Date	March 23, 2020
Days to Decision	101 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.