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

    VARIOUS INSTRUMENTS & INSTRUMENT TRAYS

    K Number: K830219 · Decision Apr 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    875
    Registration Numbers
    875
    Same Product Code
    75
    Applicant Total
    9
    Review Days
    78

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    Basic Information

    Device Name
    VARIOUS INSTRUMENTS & INSTRUMENT TRAYS
    K Number
    K830219
    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
    January 24, 1983
    Decision Date
    April 12, 1983
    Product Code
    FSM
    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
    FSM Tray, Surgical, Instrument

    Similar 510(k) Clearances

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

    INSTRUMENT TRAY LINER

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    SINGLE USE INSTRUMENT TRAY

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    SURGICAL INSTRUMENT TRAY

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    FDA Class 1 ·General, Plastic Surgery

    ARTHROSCOPY TRAY

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    OPEN HEART TRAY

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    HEART CATH TRAY

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    Other Clearances by Ascep, Inc.

    K Number Device Name
    K822893 G.E.V. DISPOSABLE SCALPELS
    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