Tubes, Gastrointestinal (and Accessories)

Device Code: 1959

Product Code(s): KNT

Device Classification Information

Device Type ID1959
Device NameTubes, Gastrointestinal (and Accessories)
Regulation DescriptionGastrointestinal Tube And Accessories.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Gastroenterology Devices Branch (GEDB)
Submission Type510(k)
CFR Regulation Number876.5980 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKNT
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID1959
DeviceTubes, Gastrointestinal (and Accessories)
Product CodeKNT
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionGastrointestinal Tube And Accessories.
CFR Regulation Number876.5980 [🔎]
Premarket Reviews
ManufacturerDecision
ABBVIE INC.
 
SUBSTANTIALLY EQUIVALENT - KIT
 2
 
SUBSTANTIALLY EQUIVALENT
 4
ACTUATED MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
APPLIED MEDICAL TECHNOLOGY, INC.
 
SUBSTANTIALLY EQUIVALENT - KIT
 2
 
SUBSTANTIALLY EQUIVALENT
 3
BENLAN, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
C.R. BARD, INC.
 
SUBSTANTIALLY EQUIVALENT - KIT
 1
CARDINAL HEALTH 200, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
COLOPLAST MANUFACTURING US LLC
 
SUBSTANTIALLY EQUIVALENT
 1
CONSURE MEDICAL PVT LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
CONVATEC
 
SUBSTANTIALLY EQUIVALENT
 1
CONVATEC LIMITED
 
SUBSTANTIALLY EQUIVALENT
 1
CONVATEC LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
COOK, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
 
SUBSTANTIALLY EQUIVALENT - KIT
 2
CORPAK MEDSYSTEMS
 
SUBSTANTIALLY EQUIVALENT
 1
COVIDIEN
 
SUBSTANTIALLY EQUIVALENT
 3
COVIDIEN LLC
 
SUBSTANTIALLY EQUIVALENT
 1
DEGANIA SILICONE, LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
 
SUBSTANTIALLY EQUIVALENT - KIT
 2
GENERICA MEDICAL INTERNATIONAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
HALYARD HEALTH, INC.
 
SUBSTANTIALLY EQUIVALENT - KIT
 1
HOSPI CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
MAQUET CRITICAL CARE AB
 
SUBSTANTIALLY EQUIVALENT
 1
MAQUET, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SYNCRO MEDICAL INNOVATIONS, INC.
 
SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS
 1
THE METRIX COMPANY
 
SUBSTANTIALLY EQUIVALENT
 1
VERITRACT, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
XERIDIEM MEDICAL DEVICES
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Adverse Event Without Identified Device Or Use Problem
 1544
Insufficient Information
 487
Tube
 425
Leak / Splash
 391
Break
 265
Occlusion Within Device
 251
Fluid Leak
 193
Detachment Of Device Component
 185
Deflation Problem
 185
Inflation Problem
 140
Detachment Of Device Or Device Component
 132
Kinked
 110
Migration Or Expulsion Of Device
82
Knotted
 70
Burst Container Or Vessel
59
Difficult To Remove
50
Human-Device Interface Problem
 49
Use Of Device Problem
 48
Overfill
 45
Improper Or Incorrect Procedure Or Method
 44
Disconnection
 42
Material Separation
 41
Material Rupture
 39
Wire
 39
Torn Material
 38
Hole In Material
 35
Appropriate Term/Code Not Available
 35
Device Dislodged Or Dislocated
 30
Malposition Of Device
28
Partial Blockage
 26
Material Twisted / Bent
 25
Balloon
 23
Patient-Device Incompatibility
 22
Device Operates Differently Than Expected
 21
Obstruction Of Flow
 20
Device Contamination With Chemical Or Other Material
 20
Difficult To Advance
 20
Entrapment Of Device
 18
No Display / Image
 18
Defective Component
 18
Material Perforation
 17
Device Handling Problem
 16
Material Puncture / Hole
 16
Device Abrasion From Instrument Or Another Object
 16
Loss Of Or Failure To Bond
 15
Material Integrity Problem
 15
Split
 15
Crack
 14
Device Damaged Prior To Use
14
Inability To Irrigate
 13
Defective Device
 13
Retraction Problem
 13
Complete Blockage
 12
Fitting Problem
 10
Mechanical Problem
 10
Migration
 10
Product Quality Problem
 9
Positioning Problem
 9
Material Deformation
 9
Off-Label Use
 8
Difficult To Position
 8
Fracture
 8
Degraded
 8
Material Frayed
 7
Device Issue
 7
Loss Of Power
 7
Patient Device Interaction Problem
 7
Display Or Visual Feedback Problem
 6
Difficult To Insert
 6
Difficult Or Delayed Positioning
 6
Connection Problem
 6
No Audible Alarm
 6
Component Missing
6
Port
 5
Insufficient Flow Or Under Infusion
 5
Cut In Material
 5
Human Factors Issue
 5
Material Fragmentation
 5
Out-Of-Box Failure
 5
Device Misassembled During Manufacturing / Shipping
 5
Device Packaging Compromised
 4
Loose Or Intermittent Connection
 4
Guidewire
 4
Device Inoperable
 4
Seal
 4
Difficult To Flush
4
Increase In Pressure
 4
Material Split, Cut Or Torn
 3
Tip
 3
Contamination During Use
 3
Decoupling
 3
Failure To Disconnect
 3
Blocked Connection
 3
Filling Problem
 3
Collapse
 3
Nonstandard Device
 3
Incorrect, Inadequate Or Imprecise Result Or Readings
 3
Expulsion
 3
Pressure Problem
 3
Failure To Infuse
 3
Total Device Problems 5757
Recalls
Manufacturer Recall Class Date Posted
1
AbbVie Inc.
 II May-31-2017
2
AbbVie Inc.
 II Dec-17-2016
3
Abeon Medical Corporation
 II Jan-21-2016
4
Applied Medical Technology Inc
 III Feb-17-2017
5
Applied Medical Technology Inc
 II Apr-14-2016
6
Boston Scientific Corp
 II Jun-25-2015
7
CORPAK MedSystems, Inc.
 II May-25-2017
8
COVIDIEN LLC
 II Dec-11-2018
9
Convatec Inc.
 I Jun-13-2014
10
Cook Inc.
 II Mar-01-2018
11
Covidien LLC
 II Feb-20-2018
12
Covidien LLC
 II Mar-02-2016
13
Neomed Inc
 III Nov-30-2018
14
Teleflex Medical
 II Apr-24-2014
15
Teleflex Medical Europe Ltd
 II Apr-12-2018
TPLC Last Update: 2019-04-02 20:02:47
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