Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT

K-Number: K131015 · 2013-10-08

ApplicantCook Biotech, Inc.
Decision Date2013-10-08
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT 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 2013-10-08 under 510(k) number K131015. 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 BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT?

BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT is a medical device that received FDA 510(k) clearance on 2013-10-08. The listed applicant is Cook Biotech, Inc.. The 510(k) number is K131015.

When did BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT receive FDA 510(k) clearance?

BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT received FDA 510(k) clearance on 2013-10-08, under 510(k) number K131015.

Who is the listed applicant for BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT?

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 BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT?

The FDA product code for BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT is GXQ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K111695HYBRID GRAFTK110402BIODESIGN NIPPLE RECONSTRUCTION CYLINDERK090688COOK UROLOGICAL GRAFTK082682SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUGK082058DYNAMATRIXK073391SURGISIS BIODESIGN TISSUE GRAFT

View all 29 devices →

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.

↑