Cleared Special

TruDi? Navigation System V3 (FG-2000-00)

K231862 · Acclarent, Inc. · Ear, Nose, Throat

Jul 2023

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K231862 is an FDA 510(k) clearance for the TruDi? Navigation System V3 (FG-2000-00), 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 July 21, 2023, 28 days after receiving the submission on June 23, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K231862 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 2023
Decision Date	July 21, 2023
Days to Decision	28 days
Submission Type	Special
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.