BEUDAMED
    Product Code: NEY FDA class 2 21 CFR 878.4400

    System, Ablation, Microwave And Accessories

    General, Plastic Surgery

    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.

    View on FDA
    510(k)s
    65
    FEI Numbers
    36
    Registration Numbers
    36
    Unique Applicants
    42
    Years Active
    23

    Basic Information

    Product Code
    NEY
    Device Class
    FDA class 2
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 65 510(k) clearances via K numbers.

    K Number Device Name
    K241827 Microwave Ablation Generator (KY-2000A, KY-2100A)
    K241825 Microwave Ablation Antennas
    K240480 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)
    K240784 Temperature Sensor Probe (ABL-18TP20)
    K240518 swiftPro™ System
    K233838 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)
    K233140 Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)
    K231738 NEUWAVE™ Microwave Ablation System and Accessories
    K232241 Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)
    K232240 Microwave Ablation System (BD-GT)
    K223138 AB1 Electrosurgical Instrument, Creo Electrosurgical System
    K222388 swiftPro System
    K223581 Solero Microwave Tissue Ablation (MTA) System and Accessories
    K221883 Solero Microwave Tissue Ablation (MTA) System and Accessories
    K223272 SurBlate Ablation System
    K221672 Creo Electrosurgical System with NP1 Instrument
    K220472 NEUWAVE Microwave Ablation System and Accessories
    K213067 Solero Microwave Tissue Ablation (MTA) System and Accessories
    K201265 Disposable Microwave Therapeutic Antennas
    K201262 Microwave Therapeutic System
    K200298 ABI Instrument, Creo Electrosurgical System
    K203303 Emprint SX Ablation Platform with Thermosphere Technology
    K192406 AveCure BT Microwave Ablation System
    K200081 NEUWAVE Microwave Ablation System and Accessories
    K200003 NP1 Instrument, Creo Electrosurgical System
    K200796 Emprint Ablation System with Thermosphere Technology
    K200061 HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)
    K193232 Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology
    K183153 Microwave Ablation System
    K182250 Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm)
    K173756 Certus 140 2.45GHz Ablation System
    K181941 Swift System
    K180396 miraDry System
    K171358 Emprint SX Ablation Platform and Accessories
    K162449 Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)
    K163118 FLEX Microwave Ablation System and Accessories
    K163105 Emprint Ablation System
    K160141 miraDry System
    K160936 Certus 140 2.45GHz Ablation System
    K143203 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
    K141785 MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES
    K133821 EMPRINT ABLATION SYSTEM
    K130399 CERTUS 140 CERTUSURGGT SURGICAL TOOL
    K122217 CERTUS 140 2.45GHZ ABLATION SYSTEM
    K122762 ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR
    K113237 CERTUS 140 2.45GHZ ABLATION SYSTEM
    K100744 CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140
    K100786 MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX
    K094021 ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I
    K083157 HS AMICA
    K082819 DERMATOLOGIC TREATMENT SYSTEM (DTS) G2
    K082565 MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200
    K083537 MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
    K072687 VALLEYLAB MICROWAVE ABLATION GENERATOR
    K081042 MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES
    K072870 MICROWAVE TISSUE COAGULATION SYSTEM (MTCS)
    K070356 MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
    K070023 MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100
    K061865 FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05
    K053535 VIVAWAVE MICROWAVE ABLATION SYSTEM
    K052919 MICROSULIS TISSUE ABLATION SYSTEM
    K041340 GUIDANT MICROWAVE ABLATION SYSTEM
    K011676 VIVAWAVE MICROWAVE SYSTEM
    K013946 FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM
    K003978 AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007

    FEI Numbers

    This FDA classification entry is associated with 36 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 36 registration numbers. Click on an entry to view related FDA registrations.