Hypodermic Needle-Pro Edge Needle Protection Device

• • Terminated Z-1733-2019 FDA Class II ·initiated 11 Feb 2019

  Incorrect needle length and gage.

• 3 recalls, same reason

  • Completed Z-0898-2015 FDA Class II ·initiated 21 Nov 2014
  • Completed Z-0899-2015 FDA Class II ·initiated 21 Nov 2014
  • Completed Z-0897-2015 FDA Class II ·initiated 21 Nov 2014

  Needle is not captured in the needle safety sheath in specific lots.

510(k) Number

K041399 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Smiths Medical Asd, Inc. →

• What is the Hypodermic Needle-Pro Edge Needle Protection Device used for?

  This device is designed to protect healthcare workers from needlestick injuries by providing a barrier against accidental needle pricks during medical procedures in general hospital settings.

• Is the Hypodermic Needle-Pro Edge device reusable or single-use?

  The Hypodermic Needle-Pro Edge Needle Protection Device is supplied as a single-use product and is not intended for reuse to ensure maximum safety and effectiveness.

• What regulatory approval has the Hypodermic Needle-Pro Edge device received?

  The device has received FDA 510(k) clearance with product code FMI, which means it has been determined to be substantially equivalent to existing predicate devices.

• What are the specifications of the Hypodermic Needle-Pro Edge device?

  The device is manufactured by Smiths Medical Asd, Inc. and is designed for general hospital use. It features an engineered needle protection mechanism to prevent accidental needlestick injuries during medical procedures.