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

    Coolief Radiofrequency Generator (CRG) System

    K Number: K192491 · Decision Feb 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    36
    Applicant Total
    8
    Review Days
    163

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    Basic Information

    Device Name
    Coolief Radiofrequency Generator (CRG) System
    K Number
    K192491
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Avanos Medical, Inc.
    Date Received
    September 11, 2019
    Decision Date
    February 21, 2020
    Product Code
    GXD
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GXD Generator, Lesion, Radiofrequency

    Similar 510(k) Clearances

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

    GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)

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    Other Clearances by Avanos Medical, Inc.

    K Number Device Name
    K243572 Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La
    K241185 CORGRIP* SR NG/NI Tube Retention System
    K242057 COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
    K240965 CORTRAK* 2 Enteral Access System (20-0950)
    K220588 Avanos* CORTRAK* 2 Enteral Access System (EAS)
    K203066 COOLIEF Cooled Radiofrequency Kit Advanced
    K191340 CORTRAK* 2 Equilateral Enteral Access System