FDA 510(k)

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

Numéro K : K262774 · 2026-09-01

DemandeurGuangdong Horigen Mother & Baby Products Co., Ltd.

Date de décision2026-09-01

Code produitHGX

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : HGX)

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Source officielle

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