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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tubes, gastrointestinal (and accessories)
Regulation Description Gastrointestinal tube and accessories.
Product CodeKNT
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
ACTUATED MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMB MEDTEC
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
AVANOS MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
AVANOS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER LABORATORIES LLC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU XIN NENG YUAN MEDICAL STAPLER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC
  SUBSTANTIALLY EQUIVALENT 1
CREATIVE BALLOONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
DEGANIA SILICONE LTD.
  SUBSTANTIALLY EQUIVALENT 1
ENDOLUMIK
  SUBSTANTIALLY EQUIVALENT 1
ENDOLUMIK INC.
  SUBSTANTIALLY EQUIVALENT 1
ENVIZION MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
GRAVITAS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
HANGZHOU PRIMECARE MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDCAPTAIN LIFE SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NASER DIB GABINET LEKARKSI NASMED
  SUBSTANTIALLY EQUIVALENT 1
NASOGASTRIC FEEDING SOLUTIONS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROSYS INTERNATIONAL LTD
  SUBSTANTIALLY EQUIVALENT 1
RESHAPE LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 4
STANDARD BARIATRICS
  SUBSTANTIALLY EQUIVALENT 3
STANDARD BARIATRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOOLS FOR SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 2
WILSON-COOK MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT - KIT 1

MDR Year MDR Reports MDR Events
2020 1641 1641
2021 1652 1652
2022 1650 1650
2023 1867 1867
2024 1345 1578
2025 347 347

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4479 4712
Break 492 492
Fluid/Blood Leak 475 475
Detachment of Device or Device Component 446 446
Obstruction of Flow 250 250
Malposition of Device 245 245
Difficult to Remove 214 214
Material Rupture 201 201
Unintended Deflation 161 161
Material Split, Cut or Torn 159 159
Device Dislodged or Dislocated 144 144
Material Puncture/Hole 143 143
Leak/Splash 139 139
Material Twisted/Bent 117 117
Fracture 92 92
Material Separation 90 90
Disconnection 68 68
Crack 67 67
Migration 65 65
Patient Device Interaction Problem 52 52
Material Integrity Problem 51 51
Material Fragmentation 49 49
Complete Blockage 47 47
Inflation Problem 44 44
Burst Container or Vessel 43 43
Deflation Problem 43 43
Use of Device Problem 41 41
No Apparent Adverse Event 40 40
Insufficient Information 36 36
Device Handling Problem 28 28
Improper or Incorrect Procedure or Method 28 28
Component Missing 28 28
Defective Device 27 27
Biocompatibility 27 27
Separation Failure 27 27
Stretched 25 25
Entrapment of Device 19 19
Physical Resistance/Sticking 19 19
Material Deformation 19 19
Decrease in Pressure 19 19
Difficult to Advance 19 19
Appropriate Term/Code Not Available 17 17
Unintended Movement 17 17
Material Perforation 17 17
Product Quality Problem 16 16
Fitting Problem 16 16
Misconnection 15 15
Loose or Intermittent Connection 14 14
Device Markings/Labelling Problem 13 13
Positioning Problem 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1974 1974
Skin Infection 1922 2058
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1019 1066
Unspecified Infection 589 589
Foreign Body In Patient 425 425
Insufficient Information 380 380
No Consequences Or Impact To Patient 290 290
No Code Available 290 290
Ulcer 186 186
No Known Impact Or Consequence To Patient 167 167
Pneumothorax 158 158
Bowel Perforation 143 143
Peritonitis 138 138
Stomach Ulceration 116 116
Hemorrhage/Bleeding 113 113
Post Operative Wound Infection 107 107
Pain 82 82
Perforation 79 80
Abscess 78 78
Pneumonia 74 74
Aspiration Pneumonitis 70 70
Sepsis 59 59
Death 57 57
Gastrointestinal Hemorrhage 55 56
Tissue Breakdown 53 53
Vomiting 52 52
Discomfort 52 52
Skin Inflammation/ Irritation 50 50
Pressure Sores 49 49
Abdominal Pain 49 49
Aspiration/Inhalation 44 44
Obstruction/Occlusion 42 42
Failure of Implant 38 38
Laceration(s) 33 33
No Patient Involvement 32 32
Granuloma 26 26
Bacterial Infection 26 26
Device Embedded In Tissue or Plaque 26 26
Fluid Discharge 25 25
Inflammation 25 25
Laceration(s) of Esophagus 24 24
Necrosis 24 24
Skin Tears 22 22
Perforation of Esophagus 22 22
Unspecified Tissue Injury 21 21
Fistula 21 21
Needle Stick/Puncture 20 20
Cough 20 20
Feeding Problem 19 19
Internal Organ Perforation 18 18

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Technology Inc II Jun-28-2024
2 Avanos Medical, Inc. II Jul-23-2024
3 Avanos Medical, Inc. I Mar-01-2024
4 Avanos Medical, Inc. I May-13-2022
5 Avanos Medical, Inc. II Feb-07-2022
6 Avanos Medical, Inc. II Dec-07-2020
7 Avanos Medical, Inc. II Sep-17-2020
8 Boston Scientific Corporation II Apr-11-2024
9 C.R. Bard Inc II Jan-25-2024
10 Cardinal Health 200, LLC II Sep-26-2024
11 Hollister Incorporated II Mar-26-2021
12 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
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