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FDA 510(k)

SpaceOAR System

K-Number: K202224 · 2020-08-28

ApplicantBoston Scientific Corporation
Decision Date2020-08-28
Product CodeOVB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SpaceOAR System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2020-08-28 under approval number K202224. 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 System?

SpaceOAR System is a medical device that received FDA 510(k) clearance on 2020-08-28. It is manufactured by Boston Scientific Corporation. The 510(k) number is K202224.

When was SpaceOAR System approved by the FDA?

SpaceOAR System received FDA 510(k) clearance on 2020-08-28, under approval number K202224.

What company makes SpaceOAR System?

SpaceOAR System is manufactured by Boston Scientific Corporation.

What is the FDA product code for SpaceOAR System?

The FDA product code for SpaceOAR System 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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