FDA 510(k)

Wearable breast pump (Model: XN/MD-2249BS, ZFHF)

N.º K: K262774 · 2026-09-01

SolicitanteGuangdong Horigen Mother & Baby Products Co., Ltd.

Fecha de decisión2026-09-01

Código de productoHGX

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Wearable breast pump (Model: XN/MD-2249BS, ZFHF) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Horigen Mother & Baby Products Co., Ltd.. It received FDA 510(k) clearance on 2026-09-01 under 510(k) number K262774. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Wearable breast pump (Model: XN/MD-2249BS, ZFHF)?

Wearable breast pump (Model: XN/MD-2249BS, ZFHF) is a medical device that received FDA 510(k) clearance on 2026-09-01. The listed applicant is Guangdong Horigen Mother & Baby Products Co., Ltd.. The 510(k) number is K262774.

When did Wearable breast pump (Model: XN/MD-2249BS, ZFHF) receive FDA 510(k) clearance?

Wearable breast pump (Model: XN/MD-2249BS, ZFHF) received FDA 510(k) clearance on 2026-09-01, under 510(k) number K262774.

Who is the listed applicant for Wearable breast pump (Model: XN/MD-2249BS, ZFHF)?

The FDA 510(k) record lists Guangdong Horigen Mother & Baby Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wearable breast pump (Model: XN/MD-2249BS, ZFHF)?

The FDA product code for Wearable breast pump (Model: XN/MD-2249BS, ZFHF) is HGX.

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Otros registros que enlistan a Guangdong Horigen Mother & Baby Products Co., Ltd. como solicitante

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Dispositivos relacionados (Código: HGX)

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Fuente oficial

Ver en la base de datos de la FDA →

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