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FDA 510(k)

FlexPointer 1.5 Single Use, FlexTube 3 Single Use

K-Number: K200041 · 2020-03-10

ApplicantFiagon GmbH
Decision Date2020-03-10
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

FlexPointer 1.5 Single Use, FlexTube 3 Single Use is a medical device manufactured by Fiagon GmbH. It received FDA 510(k) clearance on 2020-03-10 under approval number K200041. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FlexPointer 1.5 Single Use, FlexTube 3 Single Use?

FlexPointer 1.5 Single Use, FlexTube 3 Single Use is a medical device that received FDA 510(k) clearance on 2020-03-10. It is manufactured by Fiagon GmbH. The 510(k) number is K200041.

When was FlexPointer 1.5 Single Use, FlexTube 3 Single Use approved by the FDA?

FlexPointer 1.5 Single Use, FlexTube 3 Single Use received FDA 510(k) clearance on 2020-03-10, under approval number K200041.

What company makes FlexPointer 1.5 Single Use, FlexTube 3 Single Use?

FlexPointer 1.5 Single Use, FlexTube 3 Single Use is manufactured by Fiagon GmbH.

What is the FDA product code for FlexPointer 1.5 Single Use, FlexTube 3 Single Use?

The FDA product code for FlexPointer 1.5 Single Use, FlexTube 3 Single Use is PGW.

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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.

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