FDA 510(k)

엔시조르 모노폴러 엔도스코픽 캔터니어

K-번호: K180134 · 2018-06-29

결정일2018-06-29

제품 코드KGE

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Ensizor Monopolar Endoscopic Scissors is the device name listed in this FDA 510(k) record. The listed applicant is Slater Endoscopy, LLC. It received FDA 510(k) clearance on 2018-06-29 under 510(k) number K180134. 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 Ensizor Monopolar Endoscopic Scissors?

Ensizor Monopolar Endoscopic Scissors is a medical device that received FDA 510(k) clearance on 2018-06-29. The listed applicant is Slater Endoscopy, LLC. The 510(k) number is K180134.

When did Ensizor Monopolar Endoscopic Scissors receive FDA 510(k) clearance?

Ensizor Monopolar Endoscopic Scissors received FDA 510(k) clearance on 2018-06-29, under 510(k) number K180134.

Who is the listed applicant for Ensizor Monopolar Endoscopic Scissors?

The FDA 510(k) record lists Slater Endoscopy, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ensizor Monopolar Endoscopic Scissors?

The FDA product code for Ensizor Monopolar Endoscopic Scissors is KGE.

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엔시조르 모노폴러 엔도스코픽 캔터니어

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: KGE)

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