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

    HORIZONS REUSABLE POLYPECTOMY SNARES

    K Number: K022268 · Decision Oct 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    62
    Applicant Total
    10
    Review Days
    102

    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
    HORIZONS REUSABLE POLYPECTOMY SNARES
    K Number
    K022268
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Horizons Intl. Corp.
    Date Received
    July 15, 2002
    Decision Date
    October 25, 2002
    Product Code
    FDI
    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
    FDI Snare, Flexible

    Similar 510(k) Clearances

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

    Advanced Tissue Resection Device

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

    Polypectomy Snare

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

    CORE-SNARE

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

    Disposable Polyp Snare

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

    Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare

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

    Disposable Polypectomy Snare

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

    Other Clearances by Horizons Intl. Corp.

    K Number Device Name
    K083049 TORNADO ROTATABEL SNARE AND POLYP CATCHER
    K022243 HORIZONS REUSABLE HOT BIOPSY FORCEPS
    K022546 HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES
    K021998 HORIZONS CYTOLOGY BRUSH
    K021706 HORIZONS HOT BIOPSY FORCEPS
    K011667 HORIZONS INTERNATIONAL POLYPECTOMY SNARES
    K010448 HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES
    K002235 HORIZONS ERCP CANNULA
    K002236 HORIZONS PAPILLOTOME