Cleared Traditional

Phasix ST Mesh with Open Positioning System

K190185 · C.R. Bard, Inc. · General & Plastic Surgery
Jun 2019
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K190185 is an FDA 510(k) clearance for the Phasix ST Mesh with Open Positioning System, 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 June 12, 2019, 131 days after receiving the submission on February 1, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K190185 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2019
Decision Date June 12, 2019
Days to Decision 131 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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