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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 K233240
Device Name GERDX-System
Applicant
G-Surg GmbH
Weinbergstrasse 28
Seeon-Seebruck,  DE 83370
Applicant Contact Julian Mair
Correspondent
novineon CRO GmbH
Friedrich-Miescher-StraBe 9
Tuebingen,  DE 72076
Correspondent Contact Anna Pocsai
Regulation Number876.1500
Classification Product Code
ODE  
Date Received09/28/2023
Decision Date 06/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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