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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K211909
Device Name Cysto-Gastro-Sets
Applicant
G-Flex Europe Sprl
20, Rue De L’Industrie
Nivelles,  BE 1400
Applicant Contact Thierry Cremer
Correspondent
G-Flex Europe Sprl
20, Rue De L’Industrie
Nivelles,  BE 1400
Correspondent Contact Thierry Cremer
Regulation Number876.4300
Classification Product Code
KNS  
Date Received06/21/2021
Decision Date 06/09/2022
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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