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

    CHICK SURGICAL LIGHT

    K Number: K862010 · Decision Jun 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    93
    Registration Numbers
    93
    Same Product Code
    25
    Applicant Total
    9
    Review Days
    12

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CHICK SURGICAL LIGHT
    K Number
    K862010
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Professional Medical Products, Inc.
    Date Received
    May 28, 1986
    Decision Date
    June 9, 1986
    Product Code
    FTA
    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
    FTA Light, Surgical, Accessories

    Similar 510(k) Clearances

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

    Universal Light Handle Cover, Light Handle Cover

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Operating Room Light Handle Adapter

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SURGICAL LIGHT HANDLE COVER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    IDSS SLC

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OASYS SURGICAL LIGHT CONTROLLER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EASYSUITE SURGICAL LIGHT CONTROL (ESLC)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Professional Medical Products, Inc.

    K Number Device Name
    K926280 STANDARD NEBULIZER HEATER
    K930270 PATIENT PREOPERATIVE PREP TRAY, SINGLE USE
    K920292 VARIOUS KITS AND TRAYS
    K860739 CHICK SURIGICAL LIGHT
    K834478 CHICK/REISON PATIENT EMERG. TROLLEY
    K830825 YIELD NON-ADHERENT DRESSING
    K822713 DERM-A-TEC SKIN BARRIER FILM
    K820413 AEGIS NON-ADHERENT DRESSING