Name: Predicase
Price: 199 USD

K-number	K241934
Device name	NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)
Applicant	Anx Robotica Corp
Product code	QKZ
Device class	Class II
Decision date	Jul 31, 2024
Decision	Substantially Equivalent
Regulation	876.1310

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Source

View the full FDA submission: accessdata.fda.gov

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NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)

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