BEUDAMED
    Product Code: NKN FDA class 2 21 CFR 880.5860

    Syringe, Piston, Reprocessed

    General Hospital

    The Reprocessed Piston Syringe is a reprocessed version of a standard piston syringe, consisting of a calibrated hollow barrel and movable plunger with a male connector at one end for attachment to a hypodermic needle, used to inject fluids into or withdraw fluids from the body; reprocessing validation data must be included in the 510(k) submission. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NKN and regulation 21 CFR 880.5860 in the General Hospital specialty. The device is not an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    NKN
    Device Class
    FDA class 2
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting

    Definition

    A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).