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

    COLONOSCOPIC INJECTION NEEDLE, C-323/C-325

    K Number: K921800 · Decision Feb 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    88
    Applicant Total
    46
    Review Days
    300

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    Basic Information

    Device Name
    COLONOSCOPIC INJECTION NEEDLE, C-323/C-325
    K Number
    K921800
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mill-Rose Laboratory
    Date Received
    April 14, 1992
    Decision Date
    February 8, 1993
    Product Code
    FBK
    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
    FBK Endoscopic Injection Needle, Gastroenterology-Urology

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    Other Clearances by Mill-Rose Laboratory

    K Number Device Name
    K983122 MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT
    K983124 MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT
    K971275 MILL-ROSE DISPOSABLE POLYPECTOMY SNARE
    K962736 MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE
    K960880 MILL-ROSE BLIND MICROBIOLOGY BRUSH
    K954519 WANG TRANSENDOSCOPIC ASPIRATION NEEDLE
    K951600 MILL-ROSE ROTATABLE POLYPECTOMY SNARE
    K954745 MILL-ROSE RIGID SCOPE CLEANING BRUSHES
    K951051 RITE-BITE BIOPSY FORCEPS
    K951048 RITE-BITE BIOPSY FORCEPS
    Search all 46 clearances from Mill-Rose Laboratory →