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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Head, Neurosurgical (Skull Clamp)
510(k) Number K262229
Device Name DORO® Headrest System for AVA
Applicant
Black Forest Medical GmbH
Boetzinger Strasse 86
Freiburg,  DE 79117
Applicant Contact Gabriel Siedle
Correspondent
Black Forest Medical GmbH
Boetzinger Strasse 86
Freiburg,  DE 79117
Correspondent Contact Gabriel Siedle
Regulation Number882.4460
Classification Product Code
HBL  
Date Received06/30/2026
Decision Date 10/27/2026
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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