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

    MOSS(R) STEEL BREAKAWAY(R) INTRODUCER

    K Number: K945480 · Decision Aug 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    31
    Applicant Total
    2
    Review Days
    293

    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
    MOSS(R) STEEL BREAKAWAY(R) INTRODUCER
    K Number
    K945480
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5090
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Harry A. Schlakman
    Date Received
    November 8, 1994
    Decision Date
    August 28, 1995
    Product Code
    KOB
    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
    KOB Catheter, Suprapubic (And Accessories)

    Similar 510(k) Clearances

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

    AMT Low-Profile Suprapubic Catheter & Drainage Set

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

    Cook Cystostomy Catheter Set

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

    One-Step Suprapubic Introducer

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

    O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set

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

    SUPRAPUBIC CATHETER AND INTRODUCER SET

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

    SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM

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

    Other Clearances by Harry A. Schlakman

    K Number Device Name
    K951122 CAPITOL URINE DRUG SCREEN COLLECTION KIT