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

    SCISSORS, UNIVERSAL, LAPAROSCOPIC W/MONOPOLAR CAUTERY REUSABLE

    K Number: K951905 · Decision Jul 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    5
    Review Days
    78

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    Basic Information

    Device Name
    SCISSORS, UNIVERSAL, LAPAROSCOPIC W/MONOPOLAR CAUTERY REUSABLE
    K Number
    K951905
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    H.S. Intl. Co., Inc.
    Date Received
    April 24, 1995
    Decision Date
    July 11, 1995
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by H.S. Intl. Co., Inc.

    K Number Device Name
    K973197 FIRE STICK
    K950852 CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP)
    K925850 DISPOSABLE UNIVERSAL LAPORASCOPIC SCISSORS
    K890544 SHAPIRO CUTTER