BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    SOFTXIL

    K Number: K171851 · Decision Mar 16, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    44
    Applicant Total
    1
    Review Days
    268

    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
    SOFTXIL
    K Number
    K171851
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bistool
    Date Received
    June 21, 2017
    Decision Date
    March 16, 2018
    Product Code
    MIB
    Advisory Committee
    Ear, Nose, Throat
    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
    MIB Elastomer, Silicone Block

    Similar 510(k) Clearances

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

    MISTI Silicone Implant

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Pre-Formed Silicone Block

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ShiNeo Silicone Implant

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    AugMENTA Penile Implant

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Pre-Formed Penile Silicone Block

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    BioSiCar Silicone Implant

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all