K-number	K232837
Device name	Uro-G HD Flexible Cystoscope
Applicant	Uroviu Corporation
Product code	FAJ
Device class	Class II
Decision date	Jun 7, 2024
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Uro-G HD Flexible Cystoscope

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