SpaceOAR Vue Hydrogel
K-Number: K182971 · 2019-07-19
ApplicantAugmenix, Inc.
Decision Date2019-07-19
Product CodeOVB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SpaceOAR Vue Hydrogel is a medical device manufactured by Augmenix, Inc.. It received FDA 510(k) clearance on 2019-07-19 under approval number K182971. 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 Hydrogel?
SpaceOAR Vue Hydrogel is a medical device that received FDA 510(k) clearance on 2019-07-19. It is manufactured by Augmenix, Inc.. The 510(k) number is K182971.
When was SpaceOAR Vue Hydrogel approved by the FDA?
SpaceOAR Vue Hydrogel received FDA 510(k) clearance on 2019-07-19, under approval number K182971.
What company makes SpaceOAR Vue Hydrogel?
SpaceOAR Vue Hydrogel is manufactured by Augmenix, Inc..
What is the FDA product code for SpaceOAR Vue Hydrogel?
The FDA product code for SpaceOAR Vue Hydrogel is OVB.
Related Clinical Trials
Other Devices by Augmenix, Inc.
Related Devices (Code: OVB)
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.