BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE

    K Number: K924753 · Decision Dec 15, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    4
    Review Days
    84

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    Basic Information

    Device Name
    BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE
    K Number
    K924753
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1810
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bioenterics Corp.
    Date Received
    September 22, 1992
    Decision Date
    December 15, 1992
    Product Code
    HMJ
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HMJ Screen, Tangent, Projection, Battery-Powered

    Similar 510(k) Clearances

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    Other Clearances by Bioenterics Corp.

    K Number Device Name
    K002838 GASTRIC SUCTION AND DRAINAGE CATHETER
    K964561 ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA
    K934084 BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE