Product Classification

• Device: syringe, piston, reprocessed
• Regulation Description: Piston syringe.
• Definition: A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body. 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: NKN
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(k)
• Regulation Number: 880.5860
• 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
• 6-382 ISO 11608-7 First edition 2016-08-01
  Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment
• 6-475 ISO 11608-4:2022
  Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics
• 6-476 ISO 11608-2:2022
  Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles
• 6-477 ISO 11608-3:2022
  Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths
• 6-478 ISO 11608-1:2022
  Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
• 6-479 ISO 11608-5:2022
  Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions

Third Party Review

Not Third Party Eligible