K232003
- 510(k) number
- K232003
- Device name
- Endoscopic Video Image Processor, Single-Use Video Hysteroscope
- Applicant
- Guangzhou Red Pine Medical Instrument Co., Ltd. CN
- Product code
- HIH — Hysteroscope (And Accessories)
- Decision date
- 2024-02-12
- Date received
- 2023-07-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K232003.pdf
Official FDA record: K232003
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.