FDA 510(k)

FlexPointer 1.5 Single Use, FlexTube 3 Single Use

K-번호: K200041 · 2020-03-10

결정일2020-03-10

제품 코드PGW

자문 위원회NE

결정Substantially Equivalent

기기 요약

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

자주 묻는 질문

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. The listed applicant is Fiagon GmbH. The 510(k) number is K200041.

When did FlexPointer 1.5 Single Use, FlexTube 3 Single Use receive FDA 510(k) clearance?

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

Who is the listed applicant for FlexPointer 1.5 Single Use, FlexTube 3 Single Use?

The FDA 510(k) record lists Fiagon GmbH as the applicant. This does not by itself establish the device manufacturer.

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.

Fiagon GmbH를 신청인으로 등재한 기타 기록

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