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FDA 510(k)

Phasix ST Parastomal Hernia Mesh

K-Number: K261543 · 2026-09-28

ApplicantDavol, Inc., A Subsidiary of C.R. Bard, Inc.
Decision Date2026-09-28
Product CodeOWT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Phasix ST Parastomal Hernia Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Davol, Inc., A Subsidiary of C.R. Bard, Inc.. It received FDA 510(k) clearance on 2026-09-28 under 510(k) number K261543. 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 Phasix ST Parastomal Hernia Mesh?

Phasix ST Parastomal Hernia Mesh is a medical device that received FDA 510(k) clearance on 2026-09-28. The listed applicant is Davol, Inc., A Subsidiary of C.R. Bard, Inc.. The 510(k) number is K261543.

When did Phasix ST Parastomal Hernia Mesh receive FDA 510(k) clearance?

Phasix ST Parastomal Hernia Mesh received FDA 510(k) clearance on 2026-09-28, under 510(k) number K261543.

Who is the listed applicant for Phasix ST Parastomal Hernia Mesh?

The FDA 510(k) record lists Davol, Inc., A Subsidiary of C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Phasix ST Parastomal Hernia Mesh?

The FDA product code for Phasix ST Parastomal Hernia 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 Davol, Inc., A Subsidiary of C.R. Bard, 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.

K243241Phasix ST Umbilical Hernia Patch

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.

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