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510(k) Data Aggregation

    K Number
    K151405
    Device Name
    Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology
    Manufacturer
    Surgical Instrument Services and Savings(dba Medline ReNewal
    Date Cleared
    2016-01-26

    (245 days)

    Product Code
    NLQ, NLO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surgical Instrument Services and Savings(dba Medline ReNewal

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medline ReNewal Reprocessed Harmonic ACE+ Shears without Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
    Device Description
    Medline ReNewal Reprocessed Harmonic ACE+ Shears without Adaptive Tissue Technology (originally manufactured by Ethicon Endo-Surgery) are cleaned, refurbished, tested, inspected, packaged, and sterilized for an additional clinical use.
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