FDA 510(k)

Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch

N.º K: K190099 · 2019-03-15

Fecha de decisión2019-03-15

Código de productoFJL

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch is the device name listed in this FDA 510(k) record. The listed applicant is Corinth Medtech, Inc.. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K190099. The device is classified under product code FJL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch?

Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Corinth Medtech, Inc.. The 510(k) number is K190099.

When did Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch receive FDA 510(k) clearance?

Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch received FDA 510(k) clearance on 2019-03-15, under 510(k) number K190099.

Who is the listed applicant for Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch?

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

What is the FDA product code for Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch?

The FDA product code for Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch is FJL.

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Otros registros que enlistan a Corinth Medtech, Inc. como solicitante

K230205Veloxion System K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags K191335Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags K190113Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags K180752Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole K162979Veloxion System

Ver todos los 7 dispositivos →

Dispositivos relacionados (Código: FJL)

K232486KARL STORZ Monopolar Resectoscopes with HF CableKarl Storz SE & CO. KG K221893KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc.K230205Veloxion SystemCorinth Medtech, Inc.K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management BagsCorinth Medtech, Inc.K162979Veloxion SystemCorinth Medtech, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

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