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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 K112642
Device Name AQUILEX FLUID CONTROL SYSTEM H112
Applicant
W.O.M. World of Medicine AG
1480 Cambridge St.
Cambridge,  MA  02139
Applicant Contact SUSANNE RAAB
Correspondent
W.O.M. World of Medicine AG
1480 Cambridge St.
Cambridge,  MA  02139
Correspondent Contact SUSANNE RAAB
Regulation Number884.1700
Classification Product Code
HIG  
Date Received09/12/2011
Decision Date 02/06/2012
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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