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

    Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology

    K Number: K190610 · Decision Aug 15, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    26
    Applicant Total
    64
    Review Days
    157

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    Basic Information

    Device Name
    Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
    K Number
    K190610
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sterilmed, Inc.
    Date Received
    March 11, 2019
    Decision Date
    August 15, 2019
    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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    Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis

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    FDA Unclassified ·Unknown

    Medline ReNewal Reprocessed Harmonic ACE+7 Shears

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    Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis

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    Other Clearances by Sterilmed, Inc.

    K Number Device Name
    K240826 Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter
    K190478 Reprocessed ViewFlex™ Xtra ICE Catheter
    K182272 Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis
    K161700 SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
    K161086 Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)
    K153006 Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter
    K152090 Reprocessed Steerable Introducer
    K152134 Reprocessed Vessel Sealer
    K150357 Reprocessed Electrophysiology Diagnostic Catheters
    K143562 Reprocessed Cordless Ultrasonic Dissection Device
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