Name: Predicase
Price: 199 USD

K-number	K242606
Device name	Nuvis® Wireless HD Camera System (Nuvis-2K)
Applicant	Integrated Endoscopy, Inc.
Product code	GCJ
Device class	Class II
Decision date	Nov 20, 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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Nuvis® Wireless HD Camera System (Nuvis-2K)

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