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

    REPROCESSED ULTRASONIC COAGULATING SHEARS

    K Number: K093702 · Decision Mar 4, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    26
    Applicant Total
    21
    Review Days
    93

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    Basic Information

    Device Name
    REPROCESSED ULTRASONIC COAGULATING SHEARS
    K Number
    K093702
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ascent Healthcare Solutions
    Date Received
    December 1, 2009
    Decision Date
    March 4, 2010
    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)

    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

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    FDA Unclassified ·Unknown
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    Other Clearances by Ascent Healthcare Solutions

    K Number Device Name
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    K100254 REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
    K100537 REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE
    K100080 REPROCESSED TROCARS, MODEL B5LT AND CB5LT
    K092425 REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10
    K090323 REPROCESSED ELECTROPHYSIOLOGY CATHETERS
    K082023 REPROCESSED ELECTROPHYSIOLOGY CATHETERS
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    Search all 21 clearances from Ascent Healthcare Solutions →