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

    Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology

    K Number: K151405 · Decision Jan 26, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    26
    Applicant Total
    1
    Review Days
    245

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    Basic Information

    Device Name
    Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology
    K Number
    K151405
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Instrument Services and Savings(Dba Medline Renewal
    Date Received
    May 26, 2015
    Decision Date
    January 26, 2016
    Product Code
    NLQ
    Advisory Committee
    Unknown
    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
    NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NLQ), ordered by most recent decision date.

    Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)

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    FDA Unclassified ·Unknown

    Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)

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    FDA Unclassified ·Unknown

    Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)

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    FDA Unclassified ·Unknown

    Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis

    FDA 510(k)
    FDA Unclassified ·Unknown

    Medline ReNewal Reprocessed Harmonic ACE+7 Shears

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    FDA Unclassified ·Unknown

    Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology

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