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The device is intended to be used for subcutaneous and intramuscular use. The function of the Futura® Safety Syringe is designed to provide safe and reliable method of injecting medication and fluids into patients and also helps protect the healthcare worker from potential needle sticks.

The Futura® Safety Syringe functions as a conventional hypodermic syringe except for its ability to retract the contaminated needle safely inside the syringe immediately after the completion of the patient injection. Complete delivery of the syringe contents activates the retraction mechanism.

This document is a 510(k) premarket notification FDA letter for the Futura® Safety Syringe. It confirms the device is substantially equivalent to legally marketed predicate devices. Unfortunately, the provided text does not contain the acceptance criteria, details of a study that proves the device meets acceptance criteria, or any of the specific information requested in your numbered list.

The letter focuses on the regulatory approval for marketing the device based on substantial equivalence, and the "Indications for Use Statement" mentions the device's intended use and mechanism. It does not include performance metrics or study results.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided input.

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