Name: Predicase
Price: 199 USD

K-number	K221515
Device name	StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring
Applicant	Boston Scientific Corporation
Product code	FGB
Device class	Class II
Decision date	Feb 2, 2023
Decision	Substantially Equivalent
Regulation	876.1500

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring

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