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

    Medline ReNewal Reprocessed Harmonic ACE+7 Shears

    K Number: K193563 · Decision Aug 19, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    26
    Applicant Total
    6
    Review Days
    240

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    Basic Information

    Device Name
    Medline ReNewal Reprocessed Harmonic ACE+7 Shears
    K Number
    K193563
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Instrument Service and Savings Inc.(Dba Medline Ren
    Date Received
    December 23, 2019
    Decision Date
    August 19, 2020
    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)

    FDA 510(k)
    FDA Unclassified ·Unknown

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

    FDA 510(k)
    FDA Unclassified ·Unknown

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

    FDA 510(k)
    FDA Unclassified ·Unknown

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

    FDA 510(k)
    FDA Unclassified ·Unknown

    Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology

    FDA 510(k)
    FDA Unclassified ·Unknown

    Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    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)
    K182588 Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
    K170955 Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
    K153745 Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider
    K151617 Livewire Electrophysiology Catheter