Cleared Traditional

StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)

K200723 · Medtronic Navigation, Inc. · Ear, Nose, Throat

Jun 2020

Decision

99d

Days

Class 2

Risk

About This 510(k) Submission

K200723 is an FDA 510(k) clearance for the StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762), 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 June 26, 2020, 99 days after receiving the submission on March 19, 2020. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K200723 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 19, 2020
Decision Date	June 26, 2020
Days to Decision	99 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.