BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Resolv Endoscopic Hemostat System

    K Number: K234131 · Decision Jul 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    10
    Applicant Total
    10
    Review Days
    211

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    Basic Information

    Device Name
    Resolv Endoscopic Hemostat System
    K Number
    K234131
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4456
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemostasis, LLC
    Date Received
    December 28, 2023
    Decision Date
    July 26, 2024
    Product Code
    QAU
    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
    QAU Hemostatic Device For Endoscopic Gastrointestinal Use

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    Other Clearances by Hemostasis, LLC

    K Number Device Name
    K220326 PosiSep X BAM Hemostat Dressing/Intranasal Splint
    K210411 PosiSep EAR Fragmentable Ear Dressing
    K142348 OsteoSeal Bone Hemostat
    K122494 POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
    K122886 NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING
    K120958 POSISEP AND POSISEP X HEMOSTAT DRESSINGS
    K102459 NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE
    K072900 EXCELARREST FOAM
    K070211 TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM