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

    BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE

    K Number: K934084 · Decision Dec 16, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    4
    Review Days
    118

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    Basic Information

    Device Name
    BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE
    K Number
    K934084
    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
    August 20, 1993
    Decision Date
    December 16, 1993
    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

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    Other Clearances by Bioenterics Corp.

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    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
    K924753 BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE