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

    GEM Flow COUPLER Device and System

    K Number: K143589 · Decision Jan 16, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    8
    Applicant Total
    9
    Review Days
    29

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    Basic Information

    Device Name
    GEM Flow COUPLER Device and System
    K Number
    K143589
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synovis Life Technologies, Inc.
    Date Received
    December 18, 2014
    Decision Date
    January 16, 2015
    Product Code
    MVR
    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
    MVR Device, Anastomotic, Microvascular

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    K221029 PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch
    K142447 PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch
    K142461 VASCU-GUARD Peripheral Vascular Patch
    K142309 GEM Flow COUPLER Device and System
    K132727 GEM FLOW COUPLER DEVICE AND SYSTEM
    K130896 VASCULAR PROBE, VASCULAR PROBE ES