FDA 510(k)

SpaceOAR Vue System (SV-2101)

K-Number: K260119 · 2026-02-10

Decision Date2026-02-10

Product CodeOVB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SpaceOAR Vue System (SV-2101) 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 2026-02-10 under 510(k) 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. The listed applicant is Boston Scientific Corporation. The 510(k) number is K260119.

When did SpaceOAR Vue System (SV-2101) receive FDA 510(k) clearance?

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

Who is the listed applicant for SpaceOAR Vue System (SV-2101)?

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 SpaceOAR Vue System (SV-2101)?

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

Related Clinical Trials

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Related Devices (Code: OVB)

K222972BioProtect Balloon Implant™ SystemBioprotect, Ltd.K220641Barrigel Injectable GelPalette Life Sciences K202224SpaceOAR SystemBoston Scientific Corporation K182971SpaceOAR Vue HydrogelAugmenix, Inc.K181465SpaceOAR SystemAugmenix, Inc.

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.