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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: NEY FDA class 2

    System, Ablation, Microwave And Accessories

    General, Plastic Surgery

    View full classification →

    The System, Ablation, Microwave And Accessories (product code NEY) is a device that uses microwave energy to thermally ablate targeted tissues, commonly used for treatment of tumors in the liver, lung, kidney, or other organs. It is classified as an FDA Class 2 device within the General and Plastic Surgery specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Microwave Ablation Generator (KY-2000A, KY-2100A)
    Microwave Ablation Antennas
    IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)
    Temperature Sensor Probe (ABL-18TP20)
    swiftPro™ System
    Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien™ Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien™ Remote Temperature Probe (RTP20); Covidien™ Remote Temperature Probe, Bulk (RTP20B)
    Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)
    NEUWAVE™ Microwave Ablation System and Accessories
    Microwave Ablation System (BD-GT)
    Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)
    AB1 Electrosurgical Instrument, Creo Electrosurgical System
    swiftPro System
    Solero Microwave Tissue Ablation (MTA) System and Accessories
    Solero Microwave Tissue Ablation (MTA) System and Accessories
    SurBlate Ablation System
    Creo Electrosurgical System with NP1 Instrument
    NEUWAVE Microwave Ablation System and Accessories
    Solero Microwave Tissue Ablation (MTA) System and Accessories
    Disposable Microwave Therapeutic Antennas
    Microwave Therapeutic System
    ABI Instrument, Creo Electrosurgical System
    Emprint SX Ablation Platform with Thermosphere Technology
    AveCure BT Microwave Ablation System
    NEUWAVE Microwave Ablation System and Accessories
    NP1 Instrument, Creo Electrosurgical System
    Emprint Ablation System with Thermosphere Technology
    HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)
    Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology
    Microwave Ablation System
    Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm)
    Certus 140 2.45GHz Ablation System
    Swift System
    miraDry System
    Emprint SX Ablation Platform and Accessories
    Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)
    FLEX Microwave Ablation System and Accessories
    Emprint Ablation System
    miraDry System
    Certus 140 2.45GHz Ablation System
    AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe
    MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES
    EMPRINT ABLATION SYSTEM
    CERTUS 140 CERTUSURGGT SURGICAL TOOL
    CERTUS 140 2.45GHZ ABLATION SYSTEM
    ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR
    CERTUS 140 2.45GHZ ABLATION SYSTEM
    CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140
    MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX
    ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I
    HS AMICA

    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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