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510(k) Data Aggregation

    K Number
    K222388
    Device Name
    swiftPro System
    Manufacturer
    Emblation Ltd.
    Date Cleared
    2023-05-04

    (269 days)

    Product Code
    NEY
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Emblation Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The swiftPro™ System is a surface based device intended for the coagulation of soft tissue during non-invasive procedures. The swiftProTM System is not indicated for use in cardiac procedures.
    Device Description
    The swiftPro® system is a hand-held microwave generator intended to provide the functionality of the Swift® microwave treatment system in a compact and portable package. The system comprises a hand-held microwave generator and an applicator tip assembly. The generator produces microwave energy at a frequency of 8 GHz with a maximum output power of 6 Watts, the output power is restricted depending on the applicator tip attached, which delivers the microwave energy to the tissue to effect thermal heating, The swiftPro® System interface is intuitive with a quick setup for setting treatment; output power level & treatment duration (seconds). The applicator tip and the handheld generator have been designed to be only connected in a certain way with a single, simple connection mechanism. This prevents the possibility of system malfunction due to incorrect setup or confusion. The SwiftPro® applicator tips have been designed to prevent re-use to mitigate the risk of cross-contamination. The SwiftPro® system compromises of the following components: - SwiftPro® Handheld Generator - SwiftPro® Cradle - SwiftPro® URT Applicator tip (non-sterile, single use) - SwiftPro® LRT Applicator tip (non-sterile, single use)
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    K Number
    K181941
    Device Name
    Swift System
    Manufacturer
    Emblation Ltd
    Date Cleared
    2018-10-18

    (90 days)

    Product Code
    NEY
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Emblation Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Swift System is a surface based device intended for the coagulation of soft tissue during non-invasive procedures. The Swift System is not indicated for use in cardiac procedures.
    Device Description
    The Swift® System is a microwave-based system intended to delivery energy through a surface contact applicator into targeted soft tissue for the purpose of coagulating (ablation) a predefined volume of tissue. The Swift® System consists of a compact, lightweight power generator with a software free controlled interface, cable and applicator with a single use disposable tip. The generator is intended to generate microwave energy at a frequency of 8GHz, maximum output power of 20Watts, and the distal end of the applicator radiates the microwave energy to effect thermal heating in the tissue. A typical surface area would be around 5mm diameter but would depend on the power & time selected. The Swift® System interface is extremely intuitive with only two dials requiring to be set which are; output power (watts) & treatment duration (seconds). The applicator/cable connection and the generator/cable connection have been designed to only be connected in a certain way with a single, simple connection mechanism. This prevents the possibility of system malfunction due to incorrect setup or confusion. While the Swift® applicator tip has been designed to prevent re-use and hence mitigate the possibility of cross-contamination should the device not been changed from patient to patient. The Swift® System comprises of the following components: - Swift® Generator - Swift® Applicator handpiece - Swift® Applicator tip - Swift® Interconnect Cable - Swift® Footswitch (optional).
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