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

    #ES-32 SUCTION CATHETER 32 FR.

    K Number: K970890 · Decision May 23, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    14
    Review Days
    73

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    Basic Information

    Device Name
    #ES-32 SUCTION CATHETER 32 FR.
    K Number
    K970890
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tri-Med Specialties, Inc.
    Date Received
    March 11, 1997
    Decision Date
    May 23, 1997
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by Tri-Med Specialties, Inc.

    K Number Device Name
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    K950574 NEEDLE/CANNULA
    K934348 TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR
    K945160 PARACENTESIS NEEDLES/CANNULAS
    K924549 TRI-MED QUICK-STEP(TM) RECTAL TUBE
    K932015 TRI-MED INFLATABLE ESOPHAGEAL DILATOR
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