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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ear, Nose, And Throat Stereotaxic Instrument
510(k) Number K221098
Device Name Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
Applicant
Stryker Corporation
Boetzinger Strasse 41
Freiburg,  DE D-79111
Applicant Contact Maya Schiel
Correspondent
Stryker Corporation
Boetzinger Strasse 41
Freiburg,  DE D-79111
Correspondent Contact Maya Schiel
Regulation Number882.4560
Classification Product Code
PGW  
Date Received04/14/2022
Decision Date 07/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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