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FDA 510(k)

NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021);

N.º K: K232042 · 2023-10-20

SolicitanteMediconcepts Technology (Shenzhen) Company Limited
Fecha de decisión2023-10-20
Código de productoGCJ
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021); is the device name listed in this FDA 510(k) record. The listed applicant is Mediconcepts Technology (Shenzhen) Company Limited. It received FDA 510(k) clearance on 2023-10-20 under 510(k) number K232042. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021);?

NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021); is a medical device that received FDA 510(k) clearance on 2023-10-20. The listed applicant is Mediconcepts Technology (Shenzhen) Company Limited. The 510(k) number is K232042.

When did NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021); receive FDA 510(k) clearance?

NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021); received FDA 510(k) clearance on 2023-10-20, under 510(k) number K232042.

Who is the listed applicant for NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021);?

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

What is the FDA product code for NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021);?

The FDA product code for NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021); is GCJ.

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Dispositivos relacionados (Código: GCJ)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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