FDA 510(k)

Fujifilm Diathermic Slitter (FlushKnife)

K-번호: K171096 · 2017-05-09

결정일2017-05-09

제품 코드KGE

자문 위원회GU

결정Substantially Equivalent

기기 요약

Fujifilm Diathermic Slitter (FlushKnife) is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-05-09 under 510(k) number K171096. The device is classified under product code KGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Fujifilm Diathermic Slitter (FlushKnife)?

Fujifilm Diathermic Slitter (FlushKnife) is a medical device that received FDA 510(k) clearance on 2017-05-09. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K171096.

When did Fujifilm Diathermic Slitter (FlushKnife) receive FDA 510(k) clearance?

Fujifilm Diathermic Slitter (FlushKnife) received FDA 510(k) clearance on 2017-05-09, under 510(k) number K171096.

Who is the listed applicant for Fujifilm Diathermic Slitter (FlushKnife)?

The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fujifilm Diathermic Slitter (FlushKnife)?

The FDA product code for Fujifilm Diathermic Slitter (FlushKnife) is KGE.

Fujifilm Medical Systems U.S.A, Inc.를 신청인으로 등재한 기타 기록

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