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

    REFLEX HTR

    K Number: K931879 · Decision Mar 24, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    33
    Review Days
    344

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    Basic Information

    Device Name
    REFLEX HTR
    K Number
    K931879
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Richard-Allan Medical Ind., Inc.
    Date Received
    April 14, 1993
    Decision Date
    March 24, 1994
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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

    K Number Device Name
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    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. →