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510(k) K202224

Device
SpaceOAR System
Applicant
Boston Scientific Corporation
510(k) number
K202224
Product code
OVB  
Decision
Substantially Equivalent (SESE)
Decision date
2020-08-28
Date received
2020-08-07
Regulation
892.5725
Classification name
Hydrogel Spacer
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jeanne OToole
Address
100 Boston Scientific Way Marlboro MA US 01752 01752

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OVB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260119SpaceOAR Vue System (SV-2101)Boston Scientific Corporation2026-02-10
K222972BioProtect Balloon Implant™ SystemBioprotect, Ltd.2023-08-25
K220641Barrigel Injectable GelPalette Life Sciences2022-05-26
K182971SpaceOAR Vue HydrogelAugmenix, Inc.2019-07-19
K181465SpaceOAR SystemAugmenix, Inc.2018-06-25
DEN140030SpaceOAR SystemAugmenix, Inc.2015-04-01

Legacy Summary#

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FDA Review#

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