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FDA 510(k)

DURASIS DURAL SUBSTITUTE

K-Number: K031850 · 2003-09-08

ApplicantCook Biotech, Inc.
Decision Date2003-09-08
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DURASIS DURAL SUBSTITUTE is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech, Inc.. It received FDA 510(k) clearance on 2003-09-08 under 510(k) number K031850. 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 DURASIS DURAL SUBSTITUTE?

DURASIS DURAL SUBSTITUTE is a medical device that received FDA 510(k) clearance on 2003-09-08. The listed applicant is Cook Biotech, Inc.. The 510(k) number is K031850.

When did DURASIS DURAL SUBSTITUTE receive FDA 510(k) clearance?

DURASIS DURAL SUBSTITUTE received FDA 510(k) clearance on 2003-09-08, under 510(k) number K031850.

Who is the listed applicant for DURASIS DURAL SUBSTITUTE?

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

What is the FDA product code for DURASIS DURAL SUBSTITUTE?

The FDA product code for DURASIS DURAL SUBSTITUTE is GXQ.

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Other records listing Cook Biotech, 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.

K131015BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFTK111695HYBRID GRAFTK110402BIODESIGN NIPPLE RECONSTRUCTION CYLINDERK090688COOK UROLOGICAL GRAFTK082682SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUGK082058DYNAMATRIX

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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.K250420Helios Dura Regeneration MatrixHelios Biomedical, Inc.K223445ArtiFasciaNurami Medical , Ltd.K212943SyntheCel Dura RepairSynthes (USA) Products, LLCK183513XenoSure Dura Biologic PatchLeMaitre Vascular, Inc.K172603Cerafix Dura SubstituteAcera Surgical, Inc.

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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