Cleared Traditional

K261543 - Phasix ST Parastomal Hernia Mesh

K261543 is an FDA 510(k) clearance for Phasix ST Parastomal Hernia Mesh, manufactured by Davol, Inc., A Subsidiary of C.R. Bard, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OWT cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K261543 · Davol, Inc., A Subsidiary of C.R. Bard, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
143d
Days
Class 2
Risk

K261543 is an FDA 510(k) clearance for the Phasix ST Parastomal Hernia Mesh. Classified as Mesh, Surgical, Absorbable, Abdominal Hernia (product code OWT), Class II - Special Controls.

Submitted by Davol, Inc., A Subsidiary of C.R. Bard, Inc. (Warwick, US). The FDA issued a Cleared decision on September 28, 2026 after a review of 143 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Davol, Inc., A Subsidiary of C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K261543

510(k) Number K261543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2026
Decision Date September 28, 2026
Days to Decision 143 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 115d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWT Device Classification - Class 2, Special Controls

Product Code OWT Mesh, Surgical, Absorbable, Abdominal Hernia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists During Hernia Repair.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OWT Mesh, Surgical, Absorbable, Abdominal Hernia

All 11
Devices cleared under the same product code (OWT) and FDA review panel - the closest regulatory comparables to K261543.
Phasix ST Umbilical Hernia Patch
K243241 · Davol, Inc., A Subsidiary of C.R. Bard, Inc. · Feb 2025
Transorb™ Self-Gripping Resorbable Mesh
K233661 · Sofradim Production · Feb 2024
TIGR Matrix Surgical Mesh, TIGR Surgical Mesh
K191749 · Novus Scientific AB · Mar 2020
GORE BIO-A Tissue Reinforcement
K191773 · W.L. Gore & Associates, Inc. · Jul 2019
Phasix ST Mesh with Open Positioning System
K190185 · C.R. Bard, Inc. · Jun 2019
Phasix ST Mesh
K173143 · C.R. Bard, Inc. · Apr 2018