K254050
- 510(k) number
- K254050
- Device name
- Manual Tissue Removal Device
- Applicant
- Suzhou AcuVu Medical Technology Co., Ltd. CN
- Product code
- HIH — Hysteroscope (And Accessories)
- Decision date
- 2026-05-15
- Date received
- 2025-12-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K254050.pdf
Official FDA record: K254050
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.