K251882
- 510(k) number
- K251882
- Device name
- Uterine Aspiration Set
- Applicant
- Gcmedica Enterprise Ltd.(Wuxi) CN
- Product code
- HHK — Curette, Suction, Endometrial (And Accessories)
- Decision date
- 2025-10-16
- Date received
- 2025-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251882.pdf
Official FDA record: K251882
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.