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

    GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE

    K Number: K971375 · Decision Oct 31, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    161
    Applicant Total
    9
    Review Days
    200

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    Basic Information

    Device Name
    GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE
    K Number
    K971375
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4760
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wilson Greatbatch Technologies, Inc.
    Date Received
    April 14, 1997
    Decision Date
    October 31, 1997
    Product Code
    EOB
    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
    EOB Nasopharyngoscope (Flexible Or Rigid)

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    Other Clearances by Wilson Greatbatch Technologies, Inc.

    K Number Device Name
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    K972280 GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES
    K971781 GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES
    K970619 GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE
    K954649 WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP
    K950063 WGL ENDOSCOPIC GRASPER*
    K942168 WGL ENDOSCOPIC GRASPER