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)

GORE BIOABSORBABLE MESH

K-Number: K033671 · 2003-12-31

ApplicantW. L. Gore & Associates, Inc.
Decision Date2003-12-31
Product CodeOWT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GORE BIOABSORBABLE MESH is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2003-12-31 under 510(k) number K033671. The device is classified under product code OWT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE BIOABSORBABLE MESH?

GORE BIOABSORBABLE MESH is a medical device that received FDA 510(k) clearance on 2003-12-31. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K033671.

When did GORE BIOABSORBABLE MESH receive FDA 510(k) clearance?

GORE BIOABSORBABLE MESH received FDA 510(k) clearance on 2003-12-31, under 510(k) number K033671.

Who is the listed applicant for GORE BIOABSORBABLE MESH?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE BIOABSORBABLE MESH?

The FDA product code for GORE BIOABSORBABLE MESH is OWT.

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 W. L. Gore & Associates, 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.

K250410GORE® Tri-Lobe Balloon CatheterK240083GORE® PROPATEN® Vascular GraftK232312GORE® PROPATEN® Vascular GraftK233551GORE® ACUSEAL Vascular GraftK231505GORE® ACUSEAL Vascular GraftK222919GORE® ENFORM Biomaterial

View all 163 devices →

Related Devices (Code: OWT)

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.

K243241Phasix ST Umbilical Hernia PatchDavol, Inc., A Subsidiary of C.R. Bard, Inc.K233661Transorb™ Self-Gripping Resorbable MeshSofradim ProductionK191749TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific ABK191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.K190185Phasix ST Mesh with Open Positioning SystemC.R. Bard, Inc.K173143Phasix ST MeshC.R. Bard, 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.

↑