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

    4 SURE TM FEEDING TUBES

    K Number: K921853 · Decision Jul 13, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    11
    Review Days
    452

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    Basic Information

    Device Name
    4 SURE TM FEEDING TUBES
    K Number
    K921853
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Boston Pacific Medical, Inc.
    Date Received
    April 17, 1992
    Decision Date
    July 13, 1993
    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 Boston Pacific Medical, Inc.

    K Number Device Name
    K933109 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS
    K922402 4 SURE TM ENTERAL FEEDING BAG
    K931048 4-SURE NELATON CATHETER
    K931047 4-SURE FEMALE CATHETER
    K921852 4 SURE TM RECTAL TUBE
    K921851 4 SURE TM SUCTION CATHETERS & KITS
    K922398 4 SURE TM ENEMA BAG SET
    K922397 4 SURE TM NASAL OXYGEN CANNULA
    K924995 4 SURE TM ANESTHESIA EXTENSION SET
    K922401 4 SURE TM COLOSTOMY POUCH
    Search all 11 clearances from Boston Pacific Medical, Inc. →