FDA.report

510(k) K960470

Device
NEURO-PATCH
Applicant
Aesculap, Inc.
510(k) number
K960470
Product code
GXQ
Decision
Substantially Equivalent (SESE)
Decision date
1996-05-10
Date received
1996-02-01
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
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
VICTORIA MACKINNON
Address
1000 Gateway Blvd. South San Francisco CA US 94080 94080

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code GXQ

510(k)DeviceApplicantDecision date
K251191Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc.2025-11-18
K250420Helios Dura Regeneration MatrixHelios Biomedical, Inc.2025-05-14
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