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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Containment System, Laparoscopic Power Morcellation, With Instrument Port
510(k) Number K192898
Device Name PneumoLiner
Applicant
Advanced Surgical Concepts
Unit 4, Sunnybank Center, Upper Dargle Road
Bray,  IE A98 E339
Applicant Contact Edward Hyland
Correspondent
Hogan Lovells US LLP
Columbia Square, 555 Thirteenth Street, NW
Washington,  DC  20004
Correspondent Contact Jonathan Kahan
Regulation Number884.4050
Classification Product Code
PMU  
Date Received10/11/2019
Decision Date 02/25/2020
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
Recalls CDRH Recalls
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