Cleared Special

K161940 - Guidewire 0.6 Single Use

K161940 is an FDA 510(k) clearance for Guidewire 0.6 Single Use, manufactured by Fiagon GmbH. The device is a Class 2 Ear, Nose, Throat device with product code PGW cleared through the Special 510(k) pathway after a 66-day FDA review.

K161940 · Fiagon GmbH · Ear, Nose, Throat device
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Sep 2016
Decision
66d
Days
Class 2
Risk

K161940 is an FDA 510(k) clearance for the Guidewire 0.6 Single Use. 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 September 18, 2016 after a review of 66 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fiagon GmbH devices

FDA 510(k) Submission Details - K161940

510(k) Number K161940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2016
Decision Date September 18, 2016
Days to Decision 66 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 89d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

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 K161940.
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Fusion Compact Navigation System
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MALLEABLE SUCTION INSTRUMENTS
K133665 · Medtronic Navigation, Inc. · Mar 2014