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

    ReNew Sterilization Trays(Catalog #3708 and #3709)

    K Number: K152745 · Decision May 12, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    8
    Review Days
    232

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    Basic Information

    Device Name
    ReNew Sterilization Trays(Catalog #3708 and #3709)
    K Number
    K152745
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microline Surgical, Inc.
    Date Received
    September 23, 2015
    Decision Date
    May 12, 2016
    Product Code
    KCT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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    Other Clearances by Microline Surgical, Inc.

    K Number Device Name
    K234147 ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M)
    K213127 ReNew Disposable Scissor Tips
    K201884 ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm
    K160706 ReNew V Handpiece Laparoscopic Instruments
    K152743 M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)
    K124029 MICROLINE FLEXIBLE LIGATING SHEARS
    K122086 THERMAL LIGATING SHEARS