Syringe, Antistick

Device Code: 2677

Product Code(s): MEG

Device Classification Information

• Device Type ID: 2677
• Device Name: Syringe, Antistick
• 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: MEG
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 5-115 ISO 80369-7 First Edition 2016-10-15
  Small-bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular Or Hypodermic Applications
• 6-11 ISO 594-1 First Edition 1986-06-15
  Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And Certain Other Medical Equipment - Part 1: General Requirements
• 6-129 ISO 594-2 Second Edition 1998-09-01
  Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And Certain Other Medical Equipment - Part 2: Lock Fittings
• 6-148 ISO 7886-3 First Edition 2005-03-01
  Sterile Hypodermic Syringes For Single Use -- Part 3: Auto-disable Syringes For Fixed-dose Immunization
• 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
• 6-278 ISO 11040-5 Third Edition 2012-02-15
  Prefilled Syringes - Part 5: Plunger Stoppers For Injectables
• 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
• 6-365 ISO 11040-4 Third Edition 2015-04-01
  Prefilled Syringes - Part 4: Glass Barrels For Injectables
• 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: 2677
• Device: Syringe, Antistick
• Product Code: MEG
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Piston Syringe.
• CFR Regulation Number: 880.5860 [🔎]

Premarket Reviews
Manufacturer	Decision
GUANGDONG HAIOU MEDICAL APPARATUS STOCK CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
REXAM HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	1
SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SOL-MILLENNIUM MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
U&U MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ULTIMED INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
WEST PHARMACEUTICAL SERVICES
	SUBSTANTIALLY EQUIVALENT	1
WEST PHARMACEUTICAL SERVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Needle	73
Safety Interlock	51
Use Of Device Problem	45
Bent	18
Break	18
Protective Measures Problem	7
Activation Problem	7
Adverse Event Without Identified Device Or Use Problem	6
Difficult To Open Or Close	5
Leak / Splash	5
Detachment Of Device Or Device Component	5
Difficult Or Delayed Activation	4
Device Or Device Fragments Location Unknown	3
Detachment Of Device Component	3
Fail-Safe Design Failure	3
Cannula	3
Failure To Deliver	2
Patient-Device Incompatibility	2
Device Damaged Prior To Use	2
Dull, Blunt	1
Hub	1
Loose Or Intermittent Connection	1
Volume Accuracy Problem	1
Device Markings / Labelling Problem	1
Device Contamination With Chemical Or Other Material	1
Material Protrusion / Extrusion	1
Device Operates Differently Than Expected	1
Device Operational Issue	1
Migration Or Expulsion Of Device	1
Safety Interlock(s) Inadequate	1
Shielding Failure	1
Syringe	1
Delivered As Unsterile Product	1
Fail-Safe Problem	1
Total Device Problems	277

Recalls
Manufacturer		Recall Class	Date Posted
1	Smiths Medical ASD, Inc.	II	Jan-08-2014
2	Terumo Medical Corp	II	Dec-24-2015

TPLC Last Update: 2019-04-02 20:17:16