Cleared Traditional

TruDi NAV Suction Instruments

K180948 · Acclarent, Inc. · Ear, Nose, Throat

Jul 2018

Decision

100d

Days

Class 2

Risk

About This 510(k) Submission

K180948 is an FDA 510(k) clearance for the TruDi NAV Suction Instruments, 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 July 20, 2018, 100 days after receiving the submission on April 11, 2018. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K180948 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 11, 2018
Decision Date	July 20, 2018
Days to Decision	100 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.