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FDA 510(k)

LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable

N.º K: K201171 · 2021-04-02

SolicitanteLeoni Fiber Optics, Inc.
Fecha de decisión2021-04-02
Código de productoGEX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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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Fuente oficial

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