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
Related Records
Applicant Contact
- Contact
- Yiannis Monovoukas
- Address
- 11 Dellbrook Rd. Weston MA US 02493 02493
FDA Registration Numbers
- 2916714
- 2245304
- 1416980
- 2249852
- 2650143
- 3027448274
- 1121308
- 3004464325
- 3012448339
- 3009039068
- 3025316685
- 3003300673
- 3012421607
- 3020659113
- 3035387162
- 3004170064
- 9681465
- 3008812560
- 1835959
- 3034676720
- 3006017180
- 1225991
- 9610612
- 3004681519
- 3009417901
- 3007284313
- 3002924436
- 3012479318
- 3000270450
- 1319660
- 1220948
- 1000393132
- 2183620
- 3002294946
- 3003418325
- 3002719998
- 1319639
- 3030126381
- 3012429393
- 2648988
Source Documents
Other 510(k) Records For Product Code GXQ
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251191 | Collagen Dura Regeneration Membrane - Repair | Collagen Matrix, Inc. | 2025-11-18 |
| K223445 | ArtiFascia | Nurami Medical , Ltd. | 2023-08-10 |
| K212943 | SyntheCel Dura Repair | Synthes (USA) Products, LLC | 2022-01-28 |
| K183513 | XenoSure Dura Biologic Patch | LeMaitre Vascular, Inc. | 2019-06-13 |
| K172603 | Cerafix Dura Substitute | Acera Surgical, Inc. | 2017-11-27 |
| K163456 | DuraGen Secure Dural Regeneration Matrix | Integra LifeSciences Corporation | 2017-01-06 |
| K161370 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2016-11-02 |
| K161278 | Cerafix Dura Substitute | Acera Surgical, Inc. | 2016-08-08 |
| K153613 | Cerafix Dura Substitute | Acera Surgical, Inc. | 2016-03-16 |
| K150825 | Collagen Dural Regeneration Matrix | Collagen Matrix, Inc. | 2015-11-20 |
| K152481 | DURAFORM Dural Graft Implant | Codman & Shurtleff, Inc. | 2015-10-30 |
| K141608 | COLLAGEN DURA MEMBRANE | Collagen Matrix, Inc. | 2015-01-16 |
| K132850 | BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM | Rti Surgical, Inc. | 2014-03-31 |
| K131792 | SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY | Synthes, Inc. | 2013-12-16 |
| K131015 | BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT | Cook Biotech, Inc. | 2013-10-08 |