Product Classification

• Device: introducer, syringe needle
• Regulation Description: Syringe needle introducer.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: KZH
• Submission Type: 510(k)
• Regulation Number: 880.6920
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 11608-4:2006 Pen-injectors for medical use -- Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
• ISO 11608-3 First edition 2000-12-15 Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test methods
• ISO 11608-1 Second edition 2012-04-01 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
• ISO 11608-2 Second edition 2012-04-01 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles
• 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

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.