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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K200041

FlexPointer 1.5 Single Use, FlexTube 3 Single Use · Fiagon GmbH · decided 2020-03-10 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
FlexPointer 1.5 single use1Fiagon GmbHPGWEFIAE0130041
FlexTube 3 single use1Fiagon GmbHPGWEFIAE0131041