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

    Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider

    K Number: K153745 · Decision May 2, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    36
    Applicant Total
    6
    Review Days
    125

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    Basic Information

    Device Name
    Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider
    K Number
    K153745
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Instrument Service and Savings Inc.(Dba Medline Ren
    Date Received
    December 29, 2015
    Decision Date
    May 2, 2016
    Product Code
    NUJ
    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
    NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

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    Other Clearances by Surgical Instrument Service and Savings Inc.(Dba Medline Ren

    K Number Device Name
    K241224 Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)
    K193563 Medline ReNewal Reprocessed Harmonic ACE+7 Shears
    K182588 Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
    K170955 Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
    K151617 Livewire Electrophysiology Catheter