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

    HEMOCLIP ECOSYSTEM

    K Number: K945520 · Decision Jan 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    6
    Review Days
    78

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    Basic Information

    Device Name
    HEMOCLIP ECOSYSTEM
    K Number
    K945520
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pilling Weck, Inc.
    Date Received
    November 10, 1994
    Decision Date
    January 27, 1995
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Pilling Weck, Inc.

    K Number Device Name
    K990547 PILLING WECK SURGICAL Y STENT FORCEPS
    K974250 VERSASTAT MULTIPOLAR SCISSORS AND CABLES
    K962771 BURKE CONGENITAL THORACOSCOPY INSTRUMENTS
    K944552 PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIP
    K943719 VISISTAT STAPLER