Product Classification

• Device: needle, hypodermic, single lumen, reprocessed
• Regulation Description: Hypodermic single lumen needle.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: NKK
• Submission Type: 510(k)
• Regulation Number: 880.5570
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 595-2 First edition 1987-12-15 Reusable all-glass or metal-and-glass syringes for medical use - Part 2: Design, performance requirements and tests
• ISO 23908 First edition 2011-06-11 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

Third Party Review

Not Third Party Eligible