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

    REFLEX(R) ESC

    K Number: K924200 · Decision Feb 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    43
    Applicant Total
    33
    Review Days
    551

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    Basic Information

    Device Name
    REFLEX(R) ESC
    K Number
    K924200
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Richard-Allan Medical Ind., Inc.
    Date Received
    August 20, 1992
    Decision Date
    February 22, 1994
    Product Code
    KNF
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

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    Other Clearances by Richard-Allan Medical Ind., Inc.

    K Number Device Name
    K931879 REFLEX HTR
    K926297 REFLEX ESI
    K924761 STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD
    K900566 RICHARD-ALLAN VESSEL LOOPS
    K896262 TITANIUM LIGATING CLIPS
    K890314 PROTECTOR (SURGICAL INSTRUMENT)
    K873309 REFLEX(TM) CA-T CLIP APPLIER
    K862404 REFLEX(TM) CLIP APPLIER
    K862223 MICRO THIN* PARAFFIN
    K861890 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2
    Search all 33 clearances from Richard-Allan Medical Ind., Inc. →