BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇦 Ukraine

    AB1 Electrosurgical Instrument, Creo Electrosurgical System

    K Number: K223138 · Decision Jun 26, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    67
    Applicant Total
    10
    Review Days
    265

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    Basic Information

    Device Name
    AB1 Electrosurgical Instrument, Creo Electrosurgical System
    K Number
    K223138
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Creo Medical, Ltd.
    Date Received
    October 4, 2022
    Decision Date
    June 26, 2023
    Product Code
    NEY
    Advisory Committee
    General, Plastic Surgery
    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
    NEY System, Ablation, Microwave And Accessories

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NEY), ordered by most recent decision date.

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    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)

    FDA 510(k)
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    Other Clearances by Creo Medical, Ltd.

    K Number Device Name
    K242774 SpydrBlade Flex Instrument (PRD-RG1-001)
    K242983 CROMA Electrosurgical Generator (PRD-EMR-050)
    K242061 Reusable Interface Cable 1.5 m (PRD-IFC-002)
    K230328 Speedboat Flush SB1 Instrument
    K221672 Creo Electrosurgical System with NP1 Instrument
    K200298 ABI Instrument, Creo Electrosurgical System
    K200003 NP1 Instrument, Creo Electrosurgical System
    K192905 Creo Electrosurgical System with HS1 Hemostasis Accessory
    K171983 Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory