Name: Predicase
Price: 199 USD

K-number	K250551
Device name	4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)
Applicant	Shenzhen Sophway Technology Co., Ltd.
Product code	GCJ
Device class	Class II
Decision date	Oct 2, 2025
Decision	Substantially Equivalent
Regulation	876.1500

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)

Everything you need for a 510(k) submission. Nothing you don't.