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FDA 510(k)

StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection

K-Number: K233645 · 2023-12-12

ApplicantBoston Scientific Corporation -
Decision Date2023-12-12
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection is a medical device manufactured by Boston Scientific Corporation -. It received FDA 510(k) clearance on 2023-12-12 under approval number K233645. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection?

StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection is a medical device that received FDA 510(k) clearance on 2023-12-12. It is manufactured by Boston Scientific Corporation -. The 510(k) number is K233645.

When was StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection approved by the FDA?

StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection received FDA 510(k) clearance on 2023-12-12, under approval number K233645.

What company makes StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection?

StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection is manufactured by Boston Scientific Corporation -.

What is the FDA product code for StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection?

The FDA product code for StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection is FGB.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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