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510(k) K250204

Endoscopic Camera System by Shenzhen Sophway Technology Co., Ltd. — Product Code FET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2025
Date Received
January 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To allow for visualization of body cavities through an endoscope by projecting images to a monitor.

Other clearances by Shenzhen Sophway Technology Co., Ltd.

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