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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K170799
Device Name AP 50/30 Insufflator with Insuflow Port
Applicant
Lexion Medical, LLC
545 Atwater Circle
St. Paul,  MN  55103
Applicant Contact Bernard Horwath
Correspondent
Hrg
4486 Timberline Ct.
St. Paul,  MN  55127
Correspondent Contact Bernard Horwath
Regulation Number884.1730
Classification Product Code
HIF  
Subsequent Product Codes
GCJ   OSV  
Date Received03/17/2017
Decision Date 11/14/2017
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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