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FDA 510(k)

SpaceOAR Flex™ System

K-Number: K262151 · 2026-09-11

ApplicantBoston Scientific Corporation
Decision Date2026-09-11
Product CodeOVB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SpaceOAR Flex™ System 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 2026-09-11 under 510(k) number K262151. 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 Flex™ System?

SpaceOAR Flex™ System is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is Boston Scientific Corporation. The 510(k) number is K262151.

When did SpaceOAR Flex™ System receive FDA 510(k) clearance?

SpaceOAR Flex™ System received FDA 510(k) clearance on 2026-09-11, under 510(k) number K262151.

Who is the listed applicant for SpaceOAR Flex™ System?

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 Flex™ System?

The FDA product code for SpaceOAR Flex™ System is OVB.

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Related Devices (Code: OVB)

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.

K260119SpaceOAR Vue System (SV-2101)Boston Scientific CorporationK222972BioProtect Balloon Implant™ SystemBioprotect, Ltd.K220641Barrigel Injectable GelPalette Life SciencesK202224SpaceOAR SystemBoston Scientific CorporationK182971SpaceOAR 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.

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