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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Hysteroscopic
510(k) Number K180825
Device Name Fluent Fluid Management System
Applicant
Hologic, Inc.
250 Campus Dr.
Malborough,  MA  01752
Applicant Contact Christine Cameron
Correspondent
Hologic, Inc.
250 Campus Dr.
Malborough,  MA  01752
Correspondent Contact Christine Cameron
Regulation Number884.1700
Classification Product Code
HIG  
Subsequent Product Code
HIH  
Date Received03/30/2018
Decision Date 08/03/2018
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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