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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: NLQ FDA unclassified

    Single-Use Reprocessed Ultrasonic Surgical Instruments

    Unknown

    View full classification →

    The Single-Use Reprocessed Ultrasonic Surgical Instruments are reprocessed versions of single-use ultrasonic surgical devices used either for fragmentation, emulsification, and aspiration of soft and hard tissue or for vessel ligation during surgical procedures; reprocessing validation data must be included in the submission. These devices are unclassified (device class "U") with an unclassified reason code of 1, subject to FDA's 510(k) pathway, under product code NLQ in the General and Plastic Surgery review panel (no regulation number assigned). The devices carry no implant or life-sustaining flags.

    510(k) Clearances

    27 matches
    K Number
    Device Name
    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)
    Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)
    Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)
    Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis
    Medline ReNewal Reprocessed Harmonic ACE+7 Shears
    Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
    Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis
    Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
    Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
    Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
    Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis
    Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology
    Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology
    Reprocessed Cordless Ultrasonic Dissection Device
    REPROCESSED HARMONIC SHEAR
    REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY
    MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS
    REPROCESSED HARMONIC SCALPEL
    REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE
    REPROCESSED ULTRASONIC COAGULATING SHEARS
    REPROCESSED HARMONIC SCALPEL
    REPROCESSED ULTRASONIC SCALPELS
    REPROCESSED HARMONIC SCALPELS
    VANGUARD REPROCESSED ULTRASONIC SCALPEL
    VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL
    MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS
    REPROCESSED HARMONIC

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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