FDA 510(k)

Reusable Monopolar Active Cord

N.º K: K192518 · 2019-10-25

Fecha de decisión2019-10-25

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Reusable Monopolar Active Cord is the device name listed in this FDA 510(k) record. The listed applicant is Us Endoscopy. It received FDA 510(k) clearance on 2019-10-25 under 510(k) number K192518. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Reusable Monopolar Active Cord?

Reusable Monopolar Active Cord is a medical device that received FDA 510(k) clearance on 2019-10-25. The listed applicant is Us Endoscopy. The 510(k) number is K192518.

When did Reusable Monopolar Active Cord receive FDA 510(k) clearance?

Reusable Monopolar Active Cord received FDA 510(k) clearance on 2019-10-25, under 510(k) number K192518.

Who is the listed applicant for Reusable Monopolar Active Cord?

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

What is the FDA product code for Reusable Monopolar Active Cord?

The FDA product code for Reusable Monopolar Active Cord is GEI.

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