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

    Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology

    K Number: K150524 · Decision Dec 16, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    26
    Applicant Total
    4
    Review Days
    289

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    Basic Information

    Device Name
    Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology
    K Number
    K150524
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Instrument Services and Savings, Inc.
    Date Received
    March 2, 2015
    Decision Date
    December 16, 2015
    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

    Medline ReNewal Reprocessed Harmonic ACE+7 Shears

    FDA 510(k)
    FDA Unclassified ·Unknown

    Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Surgical Instrument Services and Savings, Inc.

    K Number Device Name
    K232130 Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
    K162751 Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider
    K152313 Medline ReNewal Reprocessed Endopath Endoscopic Instruments