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

    SMITH & NEPHEW DYONICS LAPAROSCOPY SYSTEM

    K Number: K914919 · Decision Jan 9, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    22
    Review Days
    66

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    Basic Information

    Device Name
    SMITH & NEPHEW DYONICS LAPAROSCOPY SYSTEM
    K Number
    K914919
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Smith & Nephew Dyonics, Inc.
    Date Received
    November 4, 1991
    Decision Date
    January 9, 1992
    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 Smith & Nephew Dyonics, Inc.

    K Number Device Name
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    K954627 ECTRA II LIGAMENT RELEASE SYSTEM
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    K953695 DYONICS DISPOSABLE ARTHROSCOPIC BLADES
    K953387 ECTRA LIGAMENT RELEASE SYSTEM
    K945182 DYONICS FIXATION SCREWS
    K936071 SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE
    K934299 DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION
    K920267 DYONICS ARTHROSCOPIC KIT
    K922176 INTELIJET SUCTION SUPPLY
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