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

    M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM

    K Number: K951424 · Decision May 9, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    29
    Applicant Total
    2
    Review Days
    43

    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
    M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM
    K Number
    K951424
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4710
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    M.E.R. Surgical Co.
    Date Received
    March 27, 1995
    Decision Date
    May 9, 1995
    Product Code
    EOX
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EOX Esophagoscope (Flexible Or Rigid)

    Similar 510(k) Clearances

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

    EndoSign® Cell collection device (ES-CYT-102)

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

    EsoCheck Cell Collection Device

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

    PENTAX Medical Video Esophagoscope EE17-J10

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

    EsoCheck Cell Collection Device

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

    EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)

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

    EsoCheck Cell Collection Device

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

    Other Clearances by M.E.R. Surgical Co.

    K Number Device Name
    K944309 M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM