Introducer, Syringe Needle

Device Code: 2645

Product Code(s): KZH

Device Classification Information

• Device Type ID: 2645
• Device Name: Introducer, Syringe Needle
• Regulation Description: Syringe Needle Introducer.
• 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: 880.6920 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KZH
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

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: 2645
• Device: Introducer, Syringe Needle
• Product Code: KZH
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Syringe Needle Introducer.
• CFR Regulation Number: 880.6920 [🔎]

Premarket Reviews
Manufacturer	Decision
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
SCANDINAVIAN HEALTH LIMITED
	SUBSTANTIALLY EQUIVALENT	1
YPSOMED AG
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Unintended Ejection	146
Misfire	85
Spring Loading Mechanism	14
Needle	3
Adverse Event Without Identified Device Or Use Problem	3
Insufficient Information	2
Headset	1
Break	1
Leak / Splash	1
Cannula	1
Connection Problem	1
Use Of Device Problem	1
Device Operates Differently Than Expected	1
Device Operational Issue	1
Total Device Problems	261

Recalls
Manufacturer		Recall Class	Date Posted
1	International Medsurg Connection, Inc.	II	Aug-04-2017
2	Owen Mumford USA, Inc.	II	Apr-02-2015

TPLC Last Update: 2019-04-02 20:16:39