FDA 510(k)

ANDORATE® Válvula de Succión y ANDORATE® Válvula de Biopsia

N.º K: K230280 · 2023-05-11

Fecha de decisión2023-05-11

Código de productoKTI

Comité asesorEN

DecisiónSubstantially Equivalent

Resumen del dispositivo

ANDORATE® Suction Valve and ANDORATE® Biopsy Valve is the device name listed in this FDA 510(k) record. The listed applicant is Ga Health Company Limited. It received FDA 510(k) clearance on 2023-05-11 under 510(k) number K230280. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ANDORATE® Suction Valve and ANDORATE® Biopsy Valve?

ANDORATE® Suction Valve and ANDORATE® Biopsy Valve is a medical device that received FDA 510(k) clearance on 2023-05-11. The listed applicant is Ga Health Company Limited. The 510(k) number is K230280.

When did ANDORATE® Suction Valve and ANDORATE® Biopsy Valve receive FDA 510(k) clearance?

ANDORATE® Suction Valve and ANDORATE® Biopsy Valve received FDA 510(k) clearance on 2023-05-11, under 510(k) number K230280.

Who is the listed applicant for ANDORATE® Suction Valve and ANDORATE® Biopsy Valve?

The FDA 510(k) record lists Ga Health Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANDORATE® Suction Valve and ANDORATE® Biopsy Valve?

The FDA product code for ANDORATE® Suction Valve and ANDORATE® Biopsy Valve is KTI.

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Otros registros que enlistan a Ga Health Company Limited como solicitante

K232118Kit de Válvula ANDORATE®K231602Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing K230932Kit de Válvula ANDORATE®K223171Tubo de irrigación AquaPulse®K213095andorate Suction Valve, andorate Air/Water Valve K202838Andorate Guarda Universal de Cepillo de Endoscopio

Ver todos los 12 dispositivos →

Dispositivos relacionados (Código: KTI)

K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm ScopesCook Ireland, Ltd.K251478ClearTip TBNA TypeFinemedix Co., Ltd.K254040LungFlow Basket CatheterFree Flow Medical, Inc.K251402LIA-1 Catheter (542-1)Leadoptik, Inc.K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc.K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation

Fuente oficial

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