Product Classification

• 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 Code: PVZ
• Premarket Review: Drug Delivery and General Hospital Devices, and Human Factors (DHT3C); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(k)
• Regulation Number: 880.5570
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• aabb
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc