BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇸🇬 Singapore

    Instalief

    K Number: K172358 · Decision Jan 10, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    160

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Instalief
    K Number
    K172358
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Privi Medical Pte, Ltd.
    Date Received
    August 3, 2017
    Decision Date
    January 10, 2018
    Product Code
    LKX
    Advisory Committee
    Unknown
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LKX Device, Thermal, Hemorrhoids

    Similar 510(k) Clearances

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

    COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL

    FDA 510(k)
    FDA Unclassified ·Unknown

    CRYOSTAT

    FDA 510(k)
    FDA Unclassified ·Unknown

    HEMOR-RITE CRYOTHERAPHY

    FDA 510(k)
    FDA Unclassified ·Unknown

    ICE BATON

    FDA 510(k)
    FDA Unclassified ·Unknown

    ANU ICE

    FDA 510(k)
    FDA Unclassified ·Unknown

    HEMORRELIEF DEVICE

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all