Cleared Traditional

Phasix ST Mesh

K173143 · C.R. Bard, Inc. · General & Plastic Surgery
Apr 2018
Decision
208d
Days
Class 2
Risk

About This 510(k) Submission

K173143 is an FDA 510(k) clearance for the Phasix ST Mesh, a Mesh, Surgical, Absorbable, Abdominal Hernia (Class II — Special Controls, product code OWT), submitted by C.R. Bard, Inc. (Warwick, US). The FDA issued a Cleared decision on April 25, 2018, 208 days after receiving the submission on September 29, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K173143 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2017
Decision Date April 25, 2018
Days to Decision 208 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code OWT — Mesh, Surgical, Absorbable, Abdominal Hernia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists During Hernia Repair.

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