Leaderflex Mini and Leaderflex Nano
K-Number: K212370 · 2022-08-29
ApplicantVygon USA
Decision Date2022-08-29
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Leaderflex Mini and Leaderflex Nano is a medical device manufactured by Vygon USA. It received FDA 510(k) clearance on 2022-08-29 under approval number K212370. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Leaderflex Mini and Leaderflex Nano?
Leaderflex Mini and Leaderflex Nano is a medical device that received FDA 510(k) clearance on 2022-08-29. It is manufactured by Vygon USA. The 510(k) number is K212370.
When was Leaderflex Mini and Leaderflex Nano approved by the FDA?
Leaderflex Mini and Leaderflex Nano received FDA 510(k) clearance on 2022-08-29, under approval number K212370.
What company makes Leaderflex Mini and Leaderflex Nano?
Leaderflex Mini and Leaderflex Nano is manufactured by Vygon USA.
What is the FDA product code for Leaderflex Mini and Leaderflex Nano?
The FDA product code for Leaderflex Mini and Leaderflex Nano is FOZ.
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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.