Name: Predicase
Price: 199 USD

K-number	K221158
Device name	Single-Use Video Flexible Ureterorenoscope System
Applicant	Guangzhou Red Pine Medical Instrument Co., Ltd.
Product code	FGB
Device class	Class II
Decision date	Mar 6, 2023
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Single-Use Video Flexible Ureterorenoscope System

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