BEUDAMED
    FDA 510(k) Substantially Equivalent for Some Indications 🇺🇸 United States

    SYRINGE INJECTION GUN

    K Number: K862853 · Decision Aug 6, 1986
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    5
    Review Days
    8

    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
    SYRINGE INJECTION GUN
    K Number
    K862853
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Gastrotech, Inc.
    Date Received
    July 29, 1986
    Decision Date
    August 6, 1986
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Other Clearances by Gastrotech, Inc.

    K Number Device Name
    K890658 SYRINGE INJECTION GUN DELIVERY KITS
    K890629 ESOPHAGEAL OVERTUBE
    K883336 GASTROSTOMY FEEDING TUBE
    K883351 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING TUBE