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

    LAPAROMED LAPAROSCOPIC RETRACTOR SYSTEM

    K Number: K930569 · Decision Apr 20, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    10
    Review Days
    89

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    Basic Information

    Device Name
    LAPAROMED LAPAROSCOPIC RETRACTOR SYSTEM
    K Number
    K930569
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Laparomed Corp.
    Date Received
    January 21, 1993
    Decision Date
    April 20, 1993
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Laparomed Corp.

    K Number Device Name
    K934527 FASCIA STITCHER
    K921921 CATHETER CHOLANGIOGRAPHY
    K921053 LAPAROMED LIGATING LOOP
    K921006 LAPAROSCOPIC RETRACTOR SYSTEM
    K914066 ELECTROSURGICAL CUTTING/COAGULATION DEVICE/ACCESS
    K910074 LAPAROMED HOOK/SPATULA DEVICE
    K910219 LAPAROMED CHOLANGIOGRAM DEVICE
    K910218 LAPAROMED CHOLANGIOGRAM VACUUM DEVICE
    K905722 SUTURE APPLIER DEVICE