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

    DISPOSABLE SURGICAL HEAD SUPPORT

    K Number: K801382 · Decision Jun 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    12
    Applicant Total
    12
    Review Days
    14

    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
    DISPOSABLE SURGICAL HEAD SUPPORT
    K Number
    K801382
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4950
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Innovative Surgical Products, Inc.
    Date Received
    June 12, 1980
    Decision Date
    June 26, 1980
    Product Code
    FSE
    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
    FSE Table, Operating-Room, Manual

    Similar 510(k) Clearances

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

    THE POREX RETRACTOR TABLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MASON EQUIPMENT ORGANIZER & ASPEN

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    OPERATING ROOM STAND

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CHEMONUCLEOLYSIS TABLE EXTENSION

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    IMSI/METRIPOND HAND OPERATING TABLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SELF-CONTAINED MOBILE OPHTHAL. OPER. .

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Innovative Surgical Products, Inc.

    K Number Device Name
    K843041 HESLIN DISPOS. TUBING SET
    K840693 DISPOSABLE SCLERAL GLOBE PLUG
    K840695 PHACOEMULSIFICATION KITS
    K840694 LENS INSERTION GLIDE
    K841072 IRRIGATION, ASPIRATION TUBING SETS
    K832235 DISPOSABLE VITRECTOMY HANDPIECE
    K821496 DISPOSABLE IRRIGA/ASPIR. SYSTEM
    K820765 PLEURAL DRAINAGE RESERVOIR
    K820680 DISPOSABLE TUBING SETS
    K802973 ISPVAC TM
    Search all 12 clearances from Innovative Surgical Products, Inc. →