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

    COX DISPOSABLE CYTOLOGY BRUSHES

    K Number: K912407 · Decision Sep 10, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    43
    Applicant Total
    15
    Review Days
    103

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    Basic Information

    Device Name
    COX DISPOSABLE CYTOLOGY BRUSHES
    K Number
    K912407
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cox Medical Ent., Inc.
    Date Received
    May 30, 1991
    Decision Date
    September 10, 1991
    Product Code
    FDX
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FDX Endoscopic Cytology Brush

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    Other Clearances by Cox Medical Ent., Inc.

    K Number Device Name
    K946360 MODULAR BIOPSY FORCEP
    K950689 UCB
    K941464 BASICS ENDOSCOPY SYSTEM
    K940911 BASICS ENDOSCOPY SYSTEM
    K932790 THERMAL OPTION
    K935250 ACCU-PATH
    K924655 COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2)
    K923671 COX DISPOSABLE POLYPECTOMY SNARES
    K923672 COX DISPOSABLE ENDOSCOPE CLEANING BRUSH
    K923489 COX DISPOSABLE RETRIEVAL DEVICES
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