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510(k) Data Aggregation

    K Number
    K223272
    Device Name
    SurBlate Ablation System
    Date Cleared
    2023-02-28

    (127 days)

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

    Mima-Pro Scientific Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SurBlate™ Ablation System is intended for coagulation (thermoablation) of soft tissues. Not for use in cardiac procedures.
    Device Description
    The SurBlate™ Ablation System is an integrated system for interstitial thermoablation of soft tissues through controlled emission of microwaves. The system is composed by four interactive devices (and one optional device), namely: a) SurBlate™-GEN: a digitally controlled microwave power source, operating at 2450 MHz, and delivering up to 100 Watts CW (continuous wave). SurBlate™-GEN features a single output channel. b) SurBlate™-APPLICATOR: an interstitial single-use coaxial microwave applicator, activated by the SurBlate™-GEN and connected to SurBlate™-GEN via the SurBlate™-COAX. c) SurBlate™-PUMP: a peristaltic pump for convective applicator cooling through continuous circulation of liquid coolant, fully controlled by and attached to SurBlate™-GEN. d) SurBlate™-COAX: a microwave coaxial cable serving as a medical grade microwave transmission line used for transmitting microwave energy. Its characteristic impedance is 50 ohm. In the system, it is used to transmit microwave energy from SurBlate™-GEN to the SurBlate™ APPLICATOR. e) SurBlate™-FOOT (Optional): a foot pedal supplied with SurBlate™-GEN for remote control of energy delivery activation.
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