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

    REFLEX ESI

    K Number: K926297 · Decision Oct 15, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    33
    Review Days
    305

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    Basic Information

    Device Name
    REFLEX ESI
    K Number
    K926297
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Richard-Allan Medical Ind., Inc.
    Date Received
    December 14, 1992
    Decision Date
    October 15, 1993
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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

    K Number Device Name
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    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
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