510(k) clearance

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

FDA 510(k) source

510(k) number

K262774

Applicant

Guangdong Horigen Mother & Baby Products Co., Ltd.

Decision date

Sep 1, 2026

Date received

Aug 4, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

HGX

Device type

Pump, Breast, Powered

Device class

Class II

Regulation

21 CFR 884.5160

Advisory committee

Obstetrics/Gynecology

Statement or summary

Summary

Third party

Y

Location

Shantou, CN