Phasix ST Parastomal Hernia Mesh— 510(k) K261543

Name: FDA 510(k) clearance K261543
Creator: U.S. Food and Drug Administration
Published: 2026-09-28

Substantially Equivalent

Davol, Inc., A Subsidiary of C.R. Bard, Inc.

FDA 510(k) clearance K261543 for Phasix ST Parastomal Hernia Mesh, Substantially Equivalent on 2026-09-28. Applicant: Davol, Inc., A Subsidiary of C.R. Bard, Inc.. Device class: 2.

Summary

Phasix ST Parastomal Hernia Mesh is filed under OWT, absorbable surgical mesh for abdominal hernia repair. The device name points to parastomal hernias, which form next to a stoma. The record doesn't describe the mesh construction.

Class II, 21 CFR 878.3300. The General and Plastic Surgery panel reviewed it as a Traditional 510(k).

Davol, Inc., listed as a subsidiary of C.R. Bard, Inc., filed from Warwick, Rhode Island. Review took 143 days (May 8 to September 28, 2026).

Clearance details

Applicant: Davol, Inc., A Subsidiary of C.R. Bard, Inc.
Product code: Product code OWT
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2026-05-08
Decision date: 2026-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warwick, RI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OWT

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K243241 — Phasix ST Umbilical Hernia Patch2025-02-19
K233661 — Transorb Self-Gripping Resorbable Mesh2024-02-13
K191749 — TIGR Matrix Surgical Mesh, TIGR Surgical Mesh2020-03-26
K191773 — GORE BIO-A Tissue Reinforcement2019-07-31
K190185 — Phasix ST Mesh with Open Positioning System2019-06-12

Adverse events under product code OWT

product code OWT

Death: 3
Injury: 396
Total: 399

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.