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FDA 510(k) Applications for Medical Device Product Code "OVB"
FDA 510(k) Number
Applicant
Device Name
Decision Date
DEN140030
AUGMENIX , INC.
SpaceOAR System
04/01/2015
K182971
Augmenix, Inc
SpaceOAR Vue Hydrogel
07/19/2019
K181465
Augmenix, Inc.
SpaceOAR System
06/25/2018
K222972
BioProtect, Ltd.
BioProtect Balloon ImplantÖ System
08/25/2023
K202224
Boston Scientific Corporation
SpaceOAR System
08/28/2020
K220641
Palette Life Sciences
Barrigel Injectable Gel
05/26/2022
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