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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 3
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 1649
2021 1655 1681
2022 1650 1666
2023 1863 1871
2024 1344 1577
2025 1337 1337

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4864 5098
Break 596 623
Fluid/Blood Leak 523 526
Detachment of Device or Device Component 466 466
Malposition of Device 301 303
Difficult to Remove 268 268
Obstruction of Flow 255 255
Material Rupture 224 224
Unintended Deflation 212 212
Material Split, Cut or Torn 184 184
Material Puncture/Hole 180 180
Leak/Splash 156 156
Device Dislodged or Dislocated 155 157
Material Twisted/Bent 122 122
Material Separation 104 106
Fracture 99 99
Disconnection 86 86
Migration 72 72
Crack 71 71
Complete Blockage 71 71
Patient Device Interaction Problem 67 67
Burst Container or Vessel 66 66
Material Fragmentation 60 60
Inflation Problem 55 55
Material Integrity Problem 55 55
Deflation Problem 50 52
No Apparent Adverse Event 49 49
Use of Device Problem 43 43
Separation Failure 42 42
Insufficient Information 39 39
Improper or Incorrect Procedure or Method 30 30
Device Handling Problem 29 29
Component Missing 29 29
Defective Device 29 30
Biocompatibility 27 27
Entrapment of Device 27 27
Stretched 27 29
Unintended Movement 24 24
Physical Resistance/Sticking 23 23
Material Deformation 20 21
Product Quality Problem 20 34
Positioning Problem 20 21
Difficult to Advance 19 19
Decrease in Pressure 19 19
Material Perforation 19 19
Misconnection 17 17
Appropriate Term/Code Not Available 17 17
Fitting Problem 16 16
Inability to Irrigate 16 16
Device Markings/Labelling Problem 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2338 2351
Skin Infection 2112 2248
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1155 1207
Unspecified Infection 594 594
Foreign Body In Patient 502 502
Insufficient Information 416 422
No Consequences Or Impact To Patient 290 290
No Code Available 290 290
Ulcer 195 195
Pneumothorax 181 183
No Known Impact Or Consequence To Patient 167 174
Bowel Perforation 153 153
Peritonitis 145 145
Stomach Ulceration 142 142
Hemorrhage/Bleeding 124 124
Post Operative Wound Infection 113 113
Pain 93 93
Abscess 83 83
Perforation 82 83
Pneumonia 77 77
Aspiration Pneumonitis 75 75
Sepsis 64 64
Skin Inflammation/ Irritation 61 61
Pressure Sores 60 61
Vomiting 59 59
Gastrointestinal Hemorrhage 59 60
Death 57 57
Discomfort 56 56
Tissue Breakdown 56 56
Abdominal Pain 55 55
Aspiration/Inhalation 48 48
Obstruction/Occlusion 45 45
Failure of Implant 39 46
Laceration(s) 34 34
No Patient Involvement 32 32
Laceration(s) of Esophagus 29 29
Granuloma 29 29
Device Embedded In Tissue or Plaque 29 29
Necrosis 27 28
Bacterial Infection 26 27
Fluid Discharge 25 25
Cough 25 25
Unspecified Tissue Injury 25 25
Internal Organ Perforation 25 25
Inflammation 25 25
Skin Tears 25 25
Perforation of Esophagus 23 23
Feeding Problem 22 22
Fistula 22 25
Cellulitis 21 21

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Technology Inc II Nov-13-2025
2 Applied Medical Technology Inc II Oct-09-2025
3 Applied Medical Technology Inc II Jun-28-2024
4 Avanos Medical, Inc. II Jul-23-2024
5 Avanos Medical, Inc. I Mar-01-2024
6 Avanos Medical, Inc. I May-13-2022
7 Avanos Medical, Inc. II Feb-07-2022
8 Avanos Medical, Inc. II Dec-07-2020
9 Avanos Medical, Inc. II Sep-17-2020
10 Boston Scientific Corporation II Apr-11-2024
11 C.R. Bard Inc I May-20-2025
12 C.R. Bard Inc II Jan-25-2024
13 Cardinal Health 200, LLC II Oct-17-2025
14 Cardinal Health 200, LLC II Sep-26-2024
15 Hollister Incorporated II Mar-26-2021
16 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
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