Cleared Special

K173628 - Acclarent ENT Navigation System

K173628 is an FDA 510(k) clearance for Acclarent ENT Navigation System, manufactured by Acclarent, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code PGW cleared through the Special 510(k) pathway after a 106-day FDA review.

K173628 · Acclarent, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
106d
Days
Class 2
Risk

K173628 is an FDA 510(k) clearance for the Acclarent ENT Navigation System. Classified as Ear, Nose, And Throat Stereotaxic Instrument (product code PGW), Class II - Special Controls.

Submitted by Acclarent, Inc. (Menlo Park, US). The FDA issued a Cleared decision on March 10, 2018 after a review of 106 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K173628

510(k) Number K173628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2017
Decision Date March 10, 2018
Days to Decision 106 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
16d slower than avg
Panel avg: 90d · This submission: 106d
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 37
Devices cleared under the same product code (PGW) and FDA review panel - the closest regulatory comparables to K173628.
TruDi Navigation System
K192397 · Biosense Webster · Jan 2020
TruDi NAV Wire
K190532 · Acclarent, Inc. · May 2019
TruDi NAV Suction Instruments
K180948 · Acclarent, Inc. · Jul 2018
Scopis Extended Instrument Set EM
K171661 · Scopis GmbH · Sep 2017
StealthStationTM S8 ENT Software
K170018 · Medtronic Navigation, Inc. · May 2017
Fiagon Navigation – PointerTube Straight and PointerTube Keat
K163416 · Fiagon GmbH · Feb 2017
K173628 · Acclarent ENT Navigation System
Download PDF FDA Summary Acclarent, Inc.