Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro Syringe & Needle with Needle Protectio

• • Terminated Z-1078-04 FDA Unclassified (pre-2012) ·initiated 29 Jun 2004

  Sterility of product is not assured

510(k) Number

K011925 ↗

FDA Product Code

FMI

Models / Variants

Hypodermic Needle-Pro Needle With Needle Protection Device

Hypodermic Needle-Pro Syringe & Needle With Needle Protectio

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• Spinal Anesthesia Needles and Introducer Needles

  Class II

  FDA 510(k) K983858 Active Cleared 29 Jan 1999

• Sims Portex Anesthesia Catheter

  Class II

  FDA 510(k) K994275 Active Cleared 22 Feb 2000

• Cpap System, Model 102001

  Class II

  FDA 510(k) K001318 Active Cleared 20 Jul 2000

See all devices from Sims Portex, Inc. →