Cleared Special

Instrument Clamps Electromagnetic

K202609 · Stryker Corporation · Ear, Nose, Throat

Oct 2020

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K202609 is an FDA 510(k) clearance for the Instrument Clamps Electromagnetic, a Ear, Nose, And Throat Stereotaxic Instrument (Class II — Special Controls, product code PGW), submitted by Stryker Corporation (Freiburg, DE). The FDA issued a Cleared decision on October 9, 2020, 30 days after receiving the submission on September 9, 2020. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K202609 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	PGW — Ear, Nose, And Throat Stereotaxic Instrument
Device Class	Class II — 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.