K260259
- 510(k) number
- K260259
- Device name
- DiscreetDuo Flow Wearable Breast Pump (Model S3)
- Applicant
- Shenzhen TPH Technology Co., Ltd. CN
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2026-07-24
- Date received
- 2026-01-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K260259.pdf
Official FDA record: K260259
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.