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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rongeur, Manual
510(k) Number K242759
Device Name Geister K-Rex rongeurs
Applicant
Geister Medizin Technik GmbH
Foehrenstrasse 2
Tuttlingen,  DE 78532
Applicant Contact Florian Herb
Correspondent
Geister Medizin Technik GmbH
Foehrenstrasse 2
Tuttlingen,  DE 78532
Correspondent Contact Florian Herb
Regulation Number882.4840
Classification Product Code
HAE  
Date Received09/12/2024
Decision Date 06/06/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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