BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    G.E.V. DISPOSABLE SCALPELS

    K Number: K822893 · Decision Oct 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    25
    Applicant Total
    9
    Review Days
    24

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    Basic Information

    Device Name
    G.E.V. DISPOSABLE SCALPELS
    K Number
    K822893
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Ascep, Inc.
    Date Received
    September 28, 1982
    Decision Date
    October 22, 1982
    Product Code
    GDX
    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
    GDX Scalpel, One-Piece

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    Other Clearances by Ascep, Inc.

    K Number Device Name
    K830219 VARIOUS INSTRUMENTS & INSTRUMENT TRAYS
    K810004 STERILE DISPOSABLE INSTRUMENT TRAYS
    K802726 INSTRUMENTS NONSTERILE & STERILE
    K791886 I.V. CARE KIT
    K791885 I.V. START SET
    K791887 CENTRAL VENOUS CATHETER DRESSING TRAY
    K791888 CATHETER CARE KIT REORDER 7940&7941
    K791889 SUTURE REMOVAL TRAY, REORDER 7950&7951