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

    Instru-Safe Instrument Protection System

    K Number: K150540 · Decision Jun 22, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    9
    Review Days
    111

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    Basic Information

    Device Name
    Instru-Safe Instrument Protection System
    K Number
    K150540
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Summit Medical, Inc.
    Date Received
    March 3, 2015
    Decision Date
    June 22, 2015
    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 Summit Medical, Inc.

    K Number Device Name
    K180528 InstruSafe(R) Sterilization Container
    K162046 MINNE TIES MMF Suture System
    K151166 Instru-Safe Instrument Protection System
    K142768 Instru-Safe Instrument Protection System
    K142630 Instru-Safe Instrument Protection System
    K141513 INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
    K140289 INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
    K133015 INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM