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

    ARTHROSCOPIC IRRIGATION PUMP

    K Number: K863605 · Decision Oct 3, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    89
    Review Days
    17

    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
    ARTHROSCOPIC IRRIGATION PUMP
    K Number
    K863605
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    American Edwards Laboratories
    Date Received
    September 16, 1986
    Decision Date
    October 3, 1986
    Product Code
    HRX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HRX Arthroscope

    Similar 510(k) Clearances

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

    Digital ClarusScope System and Digital NeuroPEN System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Freedom DS™ Decompression System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VantageTM Lumbar Decompression Kit

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PUREVUE™ FMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Articulator Arthroscopic Bur

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by American Edwards Laboratories

    K Number Device Name
    K873485 EDSLAB (R) OCCLUSION BALLOON CATHETER
    K872596 TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30
    K872529 THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2
    K870444 HOMEPRO II VOLUMETRIC INFUSION PUMP
    K864997 MEDTRAC VP VOLUMETRIC INFUSION PUMP
    K864330 SHEAR FORCE GAUGE
    K862724 VEIN VALVE CUTTER
    K864155 MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS
    K863596 CHIN-FOGARTY INFLATION DEVICE
    K863986 XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES
    Search all 89 clearances from American Edwards Laboratories →