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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 the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation -. It received FDA 510(k) clearance on 2023-12-12 under 510(k) 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. The listed applicant is Boston Scientific Corporation -. The 510(k) number is K233645.

When did StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection receive FDA 510(k) clearance?

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

Who is the listed applicant for StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection?

The FDA 510(k) record lists Boston Scientific Corporation - as the applicant. This does not by itself establish the device manufacturer.

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.

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Related Devices (Code: FGB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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