FDA.reportPublic FDA data

510(k) K250420

Device
Helios Dura Regeneration Matrix
Applicant
Helios Biomedical, Inc.
510(k) number
K250420
Product code
GXQ
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-14
Date received
2025-02-13
Regulation
882.5910
Classification name
Dura Substitute
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Yiannis Monovoukas
Address
11 Dellbrook Rd. Weston MA US 02493 02493

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GXQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251191Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc.2025-11-18
K223445ArtiFasciaNurami Medical , Ltd.2023-08-10
K212943SyntheCel Dura RepairSynthes (USA) Products, LLC2022-01-28
K183513XenoSure Dura Biologic PatchLeMaitre Vascular, Inc.2019-06-13
K172603Cerafix Dura SubstituteAcera Surgical, Inc.2017-11-27
K163456DuraGen Secure Dural Regeneration MatrixIntegra LifeSciences Corporation2017-01-06
K161370Durepair Dura Regeneration MatrixMedtronic Neurosurgery2016-11-02
K161278Cerafix Dura SubstituteAcera Surgical, Inc.2016-08-08
K153613Cerafix Dura SubstituteAcera Surgical, Inc.2016-03-16
K150825Collagen Dural Regeneration MatrixCollagen Matrix, Inc.2015-11-20
K152481DURAFORM Dural Graft ImplantCodman & Shurtleff, Inc.2015-10-30
K141608COLLAGEN DURA MEMBRANECollagen Matrix, Inc.2015-01-16
K132850BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DMRti Surgical, Inc.2014-03-31
K131792SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAYSynthes, Inc.2013-12-16
K131015BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFTCook Biotech, Inc.2013-10-08