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

    MALLEUS NIPPERS

    K Number: K822198 · Decision Aug 25, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    94
    Review Days
    33

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    Basic Information

    Device Name
    MALLEUS NIPPERS
    K Number
    K822198
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Kelleher Corp.
    Date Received
    July 23, 1982
    Decision Date
    August 25, 1982
    Product Code
    JEK
    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
    JEK Forceps, Biopsy, Bronchoscope (Rigid)

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    OPTICAL FORCEPS

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

    FORCEPS FOR USE WITH RIGID ENDOSCOPES

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    FDA Class 2 ·Ear, Nose, Throat
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    Other Clearances by Kelleher Corp.

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    K823111 NYSTYMOGRAPH ACCESS
    K822252 ENT TREATMENT UNITS
    K822272 HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS
    K822017 TYMPANOSTOMY TUBES & VARIOUS TYPES
    K822257 VARIOUS TYPES OF LIGHT SOURCE HANDLES
    K822259 LARYNGEAL SPATULAS
    K822004 FACE SHIELDS
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