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FDA 510(k)

SpaceOAR Vue System (SV-2101)

K-Number: K260119 · 2026-02-10

ApplicantBoston Scientific Corporation
Decision Date2026-02-10
Product CodeOVB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SpaceOAR Vue System (SV-2101) is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2026-02-10 under approval number K260119. The device is classified under product code OVB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpaceOAR Vue System (SV-2101)?

SpaceOAR Vue System (SV-2101) is a medical device that received FDA 510(k) clearance on 2026-02-10. It is manufactured by Boston Scientific Corporation. The 510(k) number is K260119.

When was SpaceOAR Vue System (SV-2101) approved by the FDA?

SpaceOAR Vue System (SV-2101) received FDA 510(k) clearance on 2026-02-10, under approval number K260119.

What company makes SpaceOAR Vue System (SV-2101)?

SpaceOAR Vue System (SV-2101) is manufactured by Boston Scientific Corporation.

What is the FDA product code for SpaceOAR Vue System (SV-2101)?

The FDA product code for SpaceOAR Vue System (SV-2101) is OVB.

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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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