Syringe, Piston, Reprocessed

Device Code: 2695

Product Code(s): NKN

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 Lu

Device Classification Information

• Device Type ID: 2695
• Device Name: Syringe, Piston, Reprocessed
• Regulation Description: Piston Syringe.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); General Hospital Devices Branch (GHDB)
• Submission Type: 510(k)
• CFR Regulation Number: 880.5860 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NKN
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 6-174 ISO 11608-4 First Edtion 2006-03-15
  Pen-injectors For Medical Use -- Part 4: Requirements And Test Methods For Electronic And Electromechanical Pen-injectors
• 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
• 6-275 ISO 11608-2 Second Edition 2012-04-01
  Needle-based Injection Systems For Medical Use - Requirements And Test Methods - Part 2: Needles
• 6-294 ISO 11608-3 Second Edition 2012-10-01
  Needle Based Injection Systems For Medical Use - Requirements And Test Methods - Part 3: Finished Containers
• 6-341 ISO 11608-1 Third Edition 2014-12-15
  Needle-based Injection Systems For Medical Use - Requirements And Test Methods - Part 1: Needle-based Injection Systems
• 6-377 ISO 11608-5 First Edition 2012-10-01
  Needle-based Injection Systems For Medical Use - Requirements And Test Methods - Part 5: Automated Function.
• 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

Total Product Life Cycle

• Device Type ID: 2695
• Device: Syringe, Piston, Reprocessed
• Product Code: NKN
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Piston Syringe.
• CFR Regulation Number: 880.5860 [🔎]

Device Problems
Component Missing	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 20:17:31