Cleared Traditional

K143380 - Phasix ST Mesh

K143380 is the FDA 510(k) clearance for Phasix ST Mesh by C.R. Bard, Inc.. It is a Class 2 General & Plastic Surgery device (product code OWT) cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K143380 · C.R. Bard, Inc. · General & Plastic Surgery device
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Jun 2015
Decision
192d
Days
Class 2
Risk

K143380 is an FDA 510(k) clearance for the Phasix ST Mesh. Classified as Mesh, Surgical, Absorbable, Abdominal Hernia (product code OWT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Warwick, US). The FDA issued a Cleared decision on June 5, 2015 after a review of 192 days - an extended review cycle.

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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K143380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2014
Decision Date June 05, 2015
Days to Decision 192 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
77d slower than avg
Panel avg: 115d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 8
Devices cleared under the same product code (OWT) and FDA review panel - the closest regulatory comparables to K143380.
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
PHASIX PLUG AND PATCH
K120728 · C.R. Bard, Inc. · Oct 2012
GORE BIOABSORBABLE MESH
K033671 · W.L. Gore & Associates, Inc. · Dec 2003