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

    PROPPER SIGMOIDOSCOPE SUCTION INSTRUMENT

    K Number: K810506 · Decision Apr 7, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    92
    Applicant Total
    25
    Review Days
    42

    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
    PROPPER SIGMOIDOSCOPE SUCTION INSTRUMENT
    K Number
    K810506
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Propper Mfg. Co., Inc.
    Date Received
    February 24, 1981
    Decision Date
    April 7, 1981
    Product Code
    OCX
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OCX Endoscopic Irrigation/Suction System

    Similar 510(k) Clearances

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

    AUXILIARY WATER TUBE MAJ-855

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single-Use Biopsy Valve (MAJ-1555)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ArgoCap (200.52)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Endoscopic Water Pump

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Water Container (MAJ-901); Water Container (MAJ-902)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Aspiration Catheter (2189)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Propper Mfg. Co., Inc.

    K Number Device Name
    K111453 STEAM DOT BLU PROCESS INDICATOR
    K102894 CLASSIX CHEMICAL STERILIZATION INDICATOR
    K082620 ONCE-A-DAY VERTOS TEST PACK
    K031152 PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)
    K991618 BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR
    K991276 PASS/FAIL CHALLENGE PACK
    K973585 PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR
    K972747 BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320)
    K961156 ONCE-A-DAY BOWIE AND DICK TEST PACK.
    K921798 PROPPER SUPER SERACULT(R)
    Search all 25 clearances from Propper Mfg. Co., Inc. →