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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator, Laparoscopic, Unipolar (And Accessories)
510(k) Number K181124
Device Name Acessa ProVu System
Applicant
Acessa Health, Inc.
7004 Bee Cave Rd., Bldg. 3, Suite 200
Austin,  TX  78746
Applicant Contact Brian J. Bergeron
Correspondent
Acessa Health, Inc.
7004 Bee Cave Rd., Bldg. 3, Suite 200
Austin,  TX  78746
Correspondent Contact Kim Rodriguez
Regulation Number884.4160
Classification Product Code
HFG  
Subsequent Product Codes
ITX   IYO   OEW  
Date Received04/30/2018
Decision Date 09/28/2018
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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