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

    COX DISPOSABLE CYTOLOGY BRUSHES

    K Number: K914466 · Decision Oct 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    43
    Applicant Total
    15
    Review Days
    18

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    COX DISPOSABLE CYTOLOGY BRUSHES
    K Number
    K914466
    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
    October 7, 1991
    Decision Date
    October 25, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FDX), ordered by most recent decision date.

    Single Use Cytology Brush V (BC-V600P-3010)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single Use Cytology Brush

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Deflectable Brush Biopsy Set

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Brush Biopsy Set ; Deflectable Brush Biopsy Set

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    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
    Search all 15 clearances from Cox Medical Ent., Inc. →