Cysto-Gastro-Sets

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

G-Flex Europe SPRL

The following data is part of a premarket notification filed by G-flex Europe Sprl with the FDA for Cysto-gastro-sets.

Pre-market Notification Details

Device IDK211909
510k NumberK211909
Device Name:Cysto-Gastro-Sets
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant G-Flex Europe SPRL 20, Rue De L’industrie Nivelles,  BE 1400
ContactThierry Cremer
CorrespondentThierry Cremer
G-Flex Europe SPRL 20, Rue De L’industrie Nivelles,  BE 1400
Product CodeKNS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-21
Decision Date2022-06-09

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