K231260
- 510(k) number
- K231260
- Device name
- HTx Disposable Hysteroscope System
- Applicant
- Suzhou AcuVu Medical Technology Co., Ltd. CN
- Product code
- HIH — Hysteroscope (And Accessories)
- Decision date
- 2024-03-05
- Date received
- 2023-05-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K231260.pdf
Official FDA record: K231260
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.