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

    Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider

    K Number: K162751 · Decision May 1, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    36
    Applicant Total
    4
    Review Days
    213

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    Basic Information

    Device Name
    Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider
    K Number
    K162751
    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 Services and Savings, Inc.
    Date Received
    September 30, 2016
    Decision Date
    May 1, 2017
    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 Services and Savings, Inc.

    K Number Device Name
    K232130 Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
    K152313 Medline ReNewal Reprocessed Endopath Endoscopic Instruments
    K150524 Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology