Cleared Special

K202609 - Instrument Clamps Electromagnetic

K202609 is an FDA 510(k) clearance for Instrument Clamps Electromagnetic, manufactured by Stryker Corporation. The device is a Class 2 Ear, Nose, Throat device with product code PGW cleared through the Special 510(k) pathway after a 30-day FDA review.

K202609 · Stryker Corporation · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
30d
Days
Class 2
Risk

K202609 is an FDA 510(k) clearance for the Instrument Clamps Electromagnetic. Classified as Ear, Nose, And Throat Stereotaxic Instrument (product code PGW), Class II - Special Controls.

Submitted by Stryker Corporation (Freiburg, DE). The FDA issued a Cleared decision on October 9, 2020 after a review of 30 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.

FDA 510(k) Submission Details - K202609

510(k) Number K202609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2020
Decision Date October 09, 2020
Days to Decision 30 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
60d faster than avg
Panel avg: 90d · This submission: 30d
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 K202609.
TruDi Shaver Blade
K221037 · Acclarent, Inc. · Jul 2022
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
K221098 · Stryker Corporation · Jul 2022
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
K211291 · Fiagon GmbH · Jul 2021
TruDi Curette
K201174 · Acclarent, Inc. · Aug 2020
StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
K200723 · Medtronic Navigation, Inc. · Jun 2020
TruDi Probe
K193453 · Acclarent, Inc. · Mar 2020
K202609 · Instrument Clamps Electromagnetic
Download PDF FDA Summary Stryker Corporation