Sclerotherapy & Endoscopic Needles
K-Number: K222006 · 2023-04-03
ApplicantG-Flex Europe Sprl
Decision Date2023-04-03
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Sclerotherapy & Endoscopic Needles is a medical device manufactured by G-Flex Europe Sprl. It received FDA 510(k) clearance on 2023-04-03 under approval number K222006. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sclerotherapy & Endoscopic Needles?
Sclerotherapy & Endoscopic Needles is a medical device that received FDA 510(k) clearance on 2023-04-03. It is manufactured by G-Flex Europe Sprl. The 510(k) number is K222006.
When was Sclerotherapy & Endoscopic Needles approved by the FDA?
Sclerotherapy & Endoscopic Needles received FDA 510(k) clearance on 2023-04-03, under approval number K222006.
What company makes Sclerotherapy & Endoscopic Needles?
Sclerotherapy & Endoscopic Needles is manufactured by G-Flex Europe Sprl.
What is the FDA product code for Sclerotherapy & Endoscopic Needles?
The FDA product code for Sclerotherapy & Endoscopic Needles is FBK.
Other Devices by G-Flex Europe Sprl
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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.