Cysto-Gastro-Sets
K-Number: K211909 · 2022-06-09
ApplicantG-Flex Europe Sprl
Decision Date2022-06-09
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Cysto-Gastro-Sets is a medical device manufactured by G-Flex Europe Sprl. It received FDA 510(k) clearance on 2022-06-09 under approval number K211909. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cysto-Gastro-Sets?
Cysto-Gastro-Sets is a medical device that received FDA 510(k) clearance on 2022-06-09. It is manufactured by G-Flex Europe Sprl. The 510(k) number is K211909.
When was Cysto-Gastro-Sets approved by the FDA?
Cysto-Gastro-Sets received FDA 510(k) clearance on 2022-06-09, under approval number K211909.
What company makes Cysto-Gastro-Sets?
Cysto-Gastro-Sets is manufactured by G-Flex Europe Sprl.
What is the FDA product code for Cysto-Gastro-Sets?
The FDA product code for Cysto-Gastro-Sets is KNS.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.