FDA 510(k)

SpaceOAR System

K-Number: K181465 · 2018-06-25

Decision Date2018-06-25

Product CodeOVB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SpaceOAR System is the device name listed in this FDA 510(k) record. The listed applicant is Augmenix, Inc.. It received FDA 510(k) clearance on 2018-06-25 under 510(k) number K181465. 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 2018-06-25. The listed applicant is Augmenix, Inc.. The 510(k) number is K181465.

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

SpaceOAR System received FDA 510(k) clearance on 2018-06-25, under 510(k) number K181465.

Who is the listed applicant for SpaceOAR System?

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 System?

The FDA product code for SpaceOAR System is OVB.

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.

K182971SpaceOAR Vue Hydrogel

Related Devices (Code: OVB)

K260119SpaceOAR Vue System (SV-2101)Boston Scientific Corporation K222972BioProtect Balloon Implant™ SystemBioprotect, Ltd.K220641Barrigel Injectable GelPalette Life Sciences K202224SpaceOAR SystemBoston Scientific Corporation K182971SpaceOAR Vue HydrogelAugmenix, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.