• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device non-stainless steel needle
Regulation Description Hypodermic single lumen needle.
Definition A hypodermic needle is intended to inject medication and aspirate fluid, below the surface of the skin.Designed to be used with ultrasound for better visualization of needle during use.
Physical State A non-stainless steel hypodermic needle is a single lumen needle that is composed of a material that is not recognized as “stainless steel” as specified in ISO 9626: 2016. This is rigid hollow tubing may be straight and with an echogenic tip that is designed for better visualization when used with ultrasound equipment. The needle tip angles to allow for a clean entry below the surface of the skin.
Technical Method A non-stainless steel hypodermic needle is a single lumen needle that is composed of a material that is not recognized as “stainless steel” as specified in ISO 9626: 2016. The needle hub is clear for better visualization of medication for injection and fluid aspiration.
Target Area Various locations of the body for general purpose use for injection of medication and aspiration of fluid where the needle gauge and length are appropriate based on anatomy and clinical need.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodePVZ
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.5570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-