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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K180096
Device Name GDT-1000 System
Applicant
Acuvu, Inc.
1749 Broadway St.
Redwood City,  CA  94063
Applicant Contact Sam Mostafavi
Correspondent
Acuvu, Inc.
1749 Broadway St.
Redwood City,  CA  94063
Correspondent Contact Sam Mostafavi
Regulation Number884.1690
Classification Product Code
HIH  
Date Received01/16/2018
Decision Date 04/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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