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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Augmenix, Inc.. It received FDA 510(k) clearance on 2019-07-19 under 510(k) 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. The listed applicant is Augmenix, Inc.. The 510(k) number is K182971.

When did SpaceOAR Vue Hydrogel receive FDA 510(k) clearance?

SpaceOAR Vue Hydrogel received FDA 510(k) clearance on 2019-07-19, under 510(k) number K182971.

Who is the listed applicant for SpaceOAR Vue Hydrogel?

The FDA 510(k) record lists Augmenix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SpaceOAR Vue Hydrogel?

The FDA product code for SpaceOAR Vue Hydrogel is OVB.

Related Clinical Trials

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.

NCT07300631SpaceOAR Post-Market Registry StudyRECRUITING

Other records listing Augmenix, Inc. as applicant

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.

K181465SpaceOAR System

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 CorporationK181465SpaceOAR 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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