Cleared Special

K163416 - Fiagon Navigation – PointerTube Straight and PointerTube Keat

K163416 is an FDA 510(k) clearance for Fiagon Navigation – PointerTube Straigh..., 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 73-day FDA review.

K163416 · Fiagon GmbH · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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Feb 2017
Decision
73d
Days
Class 2
Risk

K163416 is an FDA 510(k) clearance for the Fiagon Navigation – PointerTube Straight and PointerTube Keat. 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 February 16, 2017 after a review of 73 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 - K163416

510(k) Number K163416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2016
Decision Date February 16, 2017
Days to Decision 73 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 90d · This submission: 73d
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 Consultant

Hogan Lovells US LLP
YARMELA PAVLOVIC

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 37
Devices cleared under the same product code (PGW) and FDA review panel - the closest regulatory comparables to K163416.
Acclarent ENT Navigation System
K173628 · Acclarent, Inc. · Mar 2018
Scopis Extended Instrument Set EM
K171661 · Scopis GmbH · Sep 2017
StealthStationTM S8 ENT Software
K170018 · Medtronic Navigation, Inc. · May 2017
Scopis Hybrid Navigation System EM
K161491 · Scopis GmbH · Feb 2017
Fiagon Navigation System
K162176 · Fiagon GmbH · Dec 2016
Acclarent NavWire Sinus Navigation Guidewire
K161697 · Acclarent, Inc. · Oct 2016