FDA 510(k)

피아곤 나비게이션 – 포인터튜브 스트레이트와 포인터튜브 키트

K-번호: K163416 · 2017-02-16

결정일2017-02-16

제품 코드PGW

자문 위원회NE

결정Substantially Equivalent

기기 요약

Fiagon Navigation – PointerTube Straight and PointerTube Keat is the device name listed in this FDA 510(k) record. The listed applicant is Fiagon GmbH. It received FDA 510(k) clearance on 2017-02-16 under 510(k) number K163416. 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 Fiagon Navigation – PointerTube Straight and PointerTube Keat?

Fiagon Navigation – PointerTube Straight and PointerTube Keat is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Fiagon GmbH. The 510(k) number is K163416.

When did Fiagon Navigation – PointerTube Straight and PointerTube Keat receive FDA 510(k) clearance?

Fiagon Navigation – PointerTube Straight and PointerTube Keat received FDA 510(k) clearance on 2017-02-16, under 510(k) number K163416.

Who is the listed applicant for Fiagon Navigation – PointerTube Straight and PointerTube Keat?

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 Fiagon Navigation – PointerTube Straight and PointerTube Keat?

The FDA product code for Fiagon Navigation – PointerTube Straight and PointerTube Keat is PGW.

Fiagon GmbH를 신청인으로 등재한 기타 기록

K261540큐브 4D 네비게이션 시스템, 비르트윅아이 프로 K230700RIWOtrack Navigation System K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System K211291큐브 나비게이션 시스템, 비르투어아이 V2, 나비게이션 센서 나노레스트, 나비게이션 유닛 큐브 4D K201472VenSure Balloon Device, VenSure Nav Balloon Device K200041FlexPointer 1.5 단용, FlexTube 3 단용

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