Name: Predicase
Price: 199 USD

K-number	K222737
Device name	Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)
Applicant	Shanghai AnQing Medical Instrument Co., Ltd.
Product code	FGB
Device class	Class II
Decision date	Oct 5, 2022
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)

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