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

    SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES

    K Number: K020719 · Decision May 10, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    282
    Applicant Total
    22
    Review Days
    66

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    Basic Information

    Device Name
    SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES
    K Number
    K020719
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4750
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Power Medical Interventions, Inc.
    Date Received
    March 5, 2002
    Decision Date
    May 10, 2002
    Product Code
    GDW
    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
    GDW Staple, Implantable

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    Other Clearances by Power Medical Interventions, Inc.

    K Number Device Name
    K091215 INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT
    K083527 INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS
    K081826 INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V
    K073001 IDRIVES, IDRIVEC, IDRIVEF
    K073148 IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS
    K071708 I45, I45S, I60, AND I60S
    K063746 POWER EXTENDERS MODEL# PEC200, PES200,PES200S
    K063075 NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS
    K061649 POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH
    K052910 POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS
    Search all 22 clearances from Power Medical Interventions, Inc. →