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FDA 510(k)

Helios Dura Regeneration Matrix

K-Number: K250420 · 2025-05-14

ApplicantHelios Biomedical, Inc.
Decision Date2025-05-14
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Helios Dura Regeneration Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Helios Biomedical, Inc.. It received FDA 510(k) clearance on 2025-05-14 under 510(k) number K250420. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Helios Dura Regeneration Matrix?

Helios Dura Regeneration Matrix is a medical device that received FDA 510(k) clearance on 2025-05-14. The listed applicant is Helios Biomedical, Inc.. The 510(k) number is K250420.

When did Helios Dura Regeneration Matrix receive FDA 510(k) clearance?

Helios Dura Regeneration Matrix received FDA 510(k) clearance on 2025-05-14, under 510(k) number K250420.

Who is the listed applicant for Helios Dura Regeneration Matrix?

The FDA 510(k) record lists Helios Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Helios Dura Regeneration Matrix?

The FDA product code for Helios Dura Regeneration Matrix is GXQ.

Other records listing Helios Biomedical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250397Helios Dermal Scaffold

Related Devices (Code: GXQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251191Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc.K223445ArtiFasciaNurami Medical , Ltd.K212943SyntheCel Dura RepairSynthes (USA) Products, LLCK183513XenoSure Dura Biologic PatchLeMaitre Vascular, Inc.K172603Cerafix Dura SubstituteAcera Surgical, Inc.K163456DuraGen Secure Dural Regeneration MatrixIntegra LifeSciences Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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