Cleared Traditional

K133573 - FIAGON NAVIGATION SYSTEM

K133573 is an FDA 510(k) clearance for FIAGON NAVIGATION SYSTEM, manufactured by Fiagon GmbH. The device is a Class 2 Ear, Nose, Throat device with product code PGW cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K133573 · Fiagon GmbH · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
161d
Days
Class 2
Risk

K133573 is an FDA 510(k) clearance for the FIAGON NAVIGATION SYSTEM. Classified as Ear, Nose, And Throat Stereotaxic Instrument (product code PGW), Class II - Special Controls.

Submitted by Fiagon GmbH (Hennigsdorf, DE). The FDA issued a Cleared decision on April 30, 2014 after a review of 161 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 882.4560 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Fiagon GmbH devices

FDA 510(k) Submission Details - K133573

510(k) Number K133573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2013
Decision Date April 30, 2014
Days to Decision 161 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 89d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PGW Device Classification - Class 2, Special Controls

Product Code PGW Ear, Nose, And Throat Stereotaxic Instrument
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - PGW Ear, Nose, And Throat Stereotaxic Instrument

All 25
Devices cleared under the same product code (PGW) and FDA review panel - the closest regulatory comparables to K133573.
KARL STORZ NAV1 Electromagnetic Navigation System
K161555 · KARL STORZ Endoscopy-America, Inc. · Oct 2016
EM ENT Navigated Suctions
K153555 · Medtronic Navigation, Inc. · Apr 2016
Fusion Compact Navigation System
K153247 · Medtronic Navigation, Inc. · Feb 2016
MALLEABLE SUCTION INSTRUMENTS
K133665 · Medtronic Navigation, Inc. · Mar 2014