Cleared Traditional

EM ENT Navigated Suctions

K153555 · Medtronic Navigation, Inc. · Ear, Nose, Throat

Apr 2016

Decision

115d

Days

Class 2

Risk

About This 510(k) Submission

K153555 is an FDA 510(k) clearance for the EM ENT Navigated Suctions, a Ear, Nose, And Throat Stereotaxic Instrument (Class II — Special Controls, product code PGW), submitted by Medtronic Navigation, Inc. (Louisville, US). The FDA issued a Cleared decision on April 7, 2016, 115 days after receiving the submission on December 14, 2015. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K153555 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 14, 2015
Decision Date	April 07, 2016
Days to Decision	115 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.