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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
510(k) Number K240879
Device Name EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
Applicant
Endogastric Solutions, Inc.
18109 NE 76th St.
Redmond,  WA  98052
Applicant Contact Shala Famil
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Columbia Sq.
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number876.1500
Classification Product Code
ODE  
Date Received03/29/2024
Decision Date 04/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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