Cleared Traditional

K161491 - Scopis Hybrid Navigation System EM

K161491 is an FDA 510(k) clearance for Scopis Hybrid Navigation System EM, manufactured by Scopis GmbH. The device is a Class 2 Ear, Nose, Throat device with product code PGW cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K161491 · Scopis GmbH · Ear, Nose, Throat device
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Feb 2017
Decision
253d
Days
Class 2
Risk

K161491 is an FDA 510(k) clearance for the Scopis Hybrid Navigation System EM. Classified as Ear, Nose, And Throat Stereotaxic Instrument (product code PGW), Class II - Special Controls.

Submitted by Scopis GmbH (Berlin, DE). The FDA issued a Cleared decision on February 9, 2017 after a review of 253 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 Scopis GmbH devices

FDA 510(k) Submission Details - K161491

510(k) Number K161491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2016
Decision Date February 09, 2017
Days to Decision 253 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
164d slower than avg
Panel avg: 89d · This submission: 253d
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 K161491.
TruDi NAV Suction Instruments
K180948 · Acclarent, Inc. · Jul 2018
Acclarent ENT Navigation System
K173628 · Acclarent, Inc. · Mar 2018
StealthStationTM S8 ENT Software
K170018 · Medtronic Navigation, Inc. · May 2017
Acclarent NavWire Sinus Navigation Guidewire
K161697 · Acclarent, Inc. · Oct 2016
KARL STORZ NAV1 Electromagnetic Navigation System
K161555 · KARL STORZ Endoscopy-America, Inc. · Oct 2016
EM ENT Navigated Suctions
K153555 · Medtronic Navigation, Inc. · Apr 2016