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

    PISTON SYRINGE

    K Number: K961877 · Decision Aug 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    7
    Review Days
    89

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    Basic Information

    Device Name
    PISTON SYRINGE
    K Number
    K961877
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Univec, Inc.
    Date Received
    May 10, 1996
    Decision Date
    August 7, 1996
    Product Code
    FMI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMI Needle, Hypodermic, Single Lumen

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    Other Clearances by Univec, Inc.

    K Number Device Name
    K020500 UNIVEC BIFURCATED SLIDING SHEATH SYRINGE
    K993996 UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
    K000747 UNIVEC TWO PIECE SYRINGE
    K933469 UNIVEC NON-REUSABLE SYRINGE
    K951619 UNIVEC NONREUSABLE LOCKING SYRINGE
    K943679 UNIVEC NONRESUSABLE LOCKING SYRINGE