Product Classification

• Device: needle, hypodermic, single lumen, reprocessed
• Regulation Description: Hypodermic single lumen needle.
• Definition: Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: NKK
• 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: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 6-273 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
• 6-507 ISO 23908 Second Edition 2024-12
  Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration - Requirements and test methods

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