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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Software Controlled Endoscope And Instrument Holder
510(k) Number K261573
Device Name ENDOSCOPE HOLDER (182214)
Applicant
Aktormed GmbH
Neugablonzer Strasse 13
Neutraubling,  DE 93073
Applicant Contact Hanna Kafurke
Correspondent
Aktormed GmbH
Neugablonzer Strasse 13
Neutraubling,  DE 93073
Correspondent Contact Hanna Kafurke
Regulation Number876.1500
Classification Product Code
QZB  
Date Received05/12/2026
Decision Date 07/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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