BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Phasix ST Mesh

    K Number: K173143 · Decision Apr 25, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    10
    Applicant Total
    645
    Review Days
    208

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Phasix ST Mesh
    K Number
    K173143
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.R. Bard, Inc.
    Date Received
    September 29, 2017
    Decision Date
    April 25, 2018
    Product Code
    OWT
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OWT Mesh, Surgical, Absorbable, Abdominal Hernia

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OWT), ordered by most recent decision date.

    Phasix ST Umbilical Hernia Patch

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Transorb™ Self-Gripping Resorbable Mesh

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TIGR Matrix Surgical Mesh, TIGR Surgical Mesh

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GORE BIO-A Tissue Reinforcement

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Phasix ST Mesh with Open Positioning System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TIGR Matrix Surgical Mesh

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by C.R. Bard, Inc.

    K Number Device Name
    K254076 BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit
    K252971 Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
    K251864 Rubber Utility Catheter
    K251186 Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
    K241334 Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,
    K230356 Aspirex™ Thrombectomy System
    K223177 Highlander™ 014 PTA Balloon Dilatation Catheter
    K222793 WavelinQ™ Generator
    K220270 Aspirex Thrombectomy System
    K213203 Provena(TM) Midline Catheter
    Search all 645 clearances from C.R. Bard, Inc. →