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

    INFANT FEEDING TUBE

    K Number: K896559 · Decision Mar 13, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    47
    Same Product Code
    58
    Applicant Total
    28
    Review Days
    116

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    INFANT FEEDING TUBE
    K Number
    K896559
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Westmark, Sterile Packing Systems, Inc. (Sps)
    Date Received
    November 17, 1989
    Decision Date
    March 13, 1990
    Product Code
    FPD
    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
    FPD Tube, Feeding

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FPD), ordered by most recent decision date.

    Nutrifit

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NUTRISAFE 2 FEEDING TUBE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Westmark, Sterile Packing Systems, Inc. (Sps)

    K Number Device Name
    K896800 IRRIGATION TRAY
    K896799 PARACERVICAL/PUDENDAL TRAYS
    K896794 SPECIMEN CONTAINER
    K896806 CATHETER PLUG/PROTECTOR
    K896798 TRACHEOSTOMY TRAY
    K896797 SUCTION CATHETER KIT
    K896215 MERCY HIP/KNEE PACK
    K896804 MANIFOLD
    K896556 UNIVERSAL POOLE SUCTION TUBE
    K896562 STOPCOCK
    Search all 28 clearances from Westmark, Sterile Packing Systems, Inc. (Sps) →