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The MFA Syringe/Needle Device is a syringe with needle intended for use in aspirating a specimen of fluid or tissue out of the human body for pathologic examination.

The MFA and predicate devices have substantially similar technological characteristics in terms of design and materials. Although there are minor difference in the characteristics of the MFA device and its predicate devices, those differences do not raise new questions of safety or efficacy. MFA differs from some predicates in the range of syringe and needle sizes but is similar to those of other predicates. Compared with the predicates, the MFA Device has a different size and shape of the hub of the needle: the size of the hub is larger and has a larger lumen to allow the collected samples to be picked up and transferred to other containers. In additional, the inner end of the needle that is located in the lumen of the hub has a cover above the opening of the needle to prohibit the collected sample getting up into the lumen of the syringe.