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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: NUJ FDA class 2

    Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

    General, Plastic Surgery

    View full classification →

    The Reprocessed Electrosurgical Cutting and Coagulation Accessories for Laparoscopic and Endoscopic Use are single-use electrosurgical instruments that have been reprocessed for reuse in laparoscopic and endoscopic surgical procedures. Reprocessing validation data must be included in the 510(k) submission for this device type per FDA guidance published at 70 FR 56911. It is an FDA Class 2 device regulated under 21 CFR 878.4400 in the General and Plastic Surgery specialty, with product code NUJ, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.

    510(k) Clearances

    37 matches
    K Number
    Device Name
    Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)
    Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
    Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
    Green OR Reprocessed Aquamantys Bipolar Sealer
    Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter
    Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
    Reprocessed LigaSure Maryland Jaw Sealer/Divider
    Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider
    NES Reprocessed RF Stylet (RFS)
    Reprocessed DePuy Mitek Ablation Wand
    Reprocessed ArthoCare Ablation Wand
    Reprocessed ArthroCare ENT Coblator
    Medline ReNewal Reprocessed Stryker SERF AS Energy Probes
    Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics
    Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider
    Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)
    Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider
    Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider
    Reprocessed Vessel Sealer
    Medline ReNewal Reprocessed Endopath Endoscopic Instruments
    Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider
    Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider
    REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
    REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM
    REPROCESSED VESSEL SEALER
    REPROCESSED SURGICAL ELECTRIC INSTRUMENT
    RESPROCESSED SERFAS ENERGY PROBE
    REPROCESSED HAND ACTIVATE SEALER/DIVIDER
    REPROCESSED ELECTROSURGICAL INSTRUMENT
    NES REPROCESSED VARICOSE VEIN RF CATHETER
    REPROCESSED SCISSOR TIPS
    SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS
    SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES
    SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS
    VANGUARD REPROCESSED ARTHROSCOPIC WANDS
    REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS
    REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS

    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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