Cleared Special

FlexPointer 1.5 Single Use, FlexTube 3 Single Use

K200041 · Fiagon GmbH · Ear, Nose, Throat

Mar 2020

Decision

62d

Days

Class 2

Risk

About This 510(k) Submission

K200041 is an FDA 510(k) clearance for the FlexPointer 1.5 Single Use, FlexTube 3 Single Use, a Ear, Nose, And Throat Stereotaxic Instrument (Class II — Special Controls, product code PGW), submitted by Fiagon GmbH (Hennigsdorf, DE). The FDA issued a Cleared decision on March 10, 2020, 62 days after receiving the submission on January 8, 2020. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K200041 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 08, 2020
Decision Date	March 10, 2020
Days to Decision	62 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.