FDA 510(k)

LEONI 레이저 파이버: 베어파이버 일회용, 베어파이버 재사용 및 엔도프로브 일회용

K-번호: K201171 · 2021-04-02

결정일2021-04-02

제품 코드GEX

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable is the device name listed in this FDA 510(k) record. The listed applicant is Leoni Fiber Optics, Inc.. It received FDA 510(k) clearance on 2021-04-02 under 510(k) number K201171. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable?

LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable is a medical device that received FDA 510(k) clearance on 2021-04-02. The listed applicant is Leoni Fiber Optics, Inc.. The 510(k) number is K201171.

When did LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable receive FDA 510(k) clearance?

LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable received FDA 510(k) clearance on 2021-04-02, under 510(k) number K201171.

Who is the listed applicant for LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable?

The FDA 510(k) record lists Leoni Fiber Optics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable?

The FDA product code for LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable is GEX. This falls under the Gastroenterology category.

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FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

LEONI 레이저 파이버: 베어파이버 일회용, 베어파이버 재사용 및 엔도프로브 일회용

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: GEX)

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