K250204
- 510(k) number
- K250204
- Device name
- Endoscopic Camera System
- Applicant
- Shenzhen Sophway Technology Co., Ltd. CN
- Product code
- FET — Endoscopic Video Imaging System/Component, Gastroent
- Decision date
- 2025-07-01
- Date received
- 2025-01-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250204.pdf
Official FDA record: K250204
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.