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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 1649
2021 1655 1681
2022 1650 1664
2023 1863 1871
2024 1344 1577
2025 1195 1195

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4814 5048
Break 579 606
Fluid/Blood Leak 508 511
Detachment of Device or Device Component 465 465
Malposition of Device 289 291
Difficult to Remove 262 262
Obstruction of Flow 254 254
Material Rupture 220 220
Unintended Deflation 207 207
Material Split, Cut or Torn 181 181
Material Puncture/Hole 174 174
Leak/Splash 154 154
Device Dislodged or Dislocated 150 152
Material Twisted/Bent 120 120
Material Separation 103 103
Fracture 98 98
Disconnection 84 84
Migration 72 72
Crack 71 71
Patient Device Interaction Problem 64 64
Complete Blockage 58 58
Material Fragmentation 58 58
Inflation Problem 55 55
Material Integrity Problem 53 53
Burst Container or Vessel 50 50
Deflation Problem 49 51
No Apparent Adverse Event 48 48
Use of Device Problem 43 43
Separation Failure 42 42
Insufficient Information 38 38
Improper or Incorrect Procedure or Method 29 29
Component Missing 29 29
Device Handling Problem 29 29
Defective Device 29 30
Stretched 27 27
Biocompatibility 27 27
Entrapment of Device 26 26
Unintended Movement 24 24
Physical Resistance/Sticking 23 23
Material Deformation 20 21
Positioning Problem 20 21
Material Perforation 19 19
Decrease in Pressure 19 19
Difficult to Advance 19 19
Product Quality Problem 18 32
Misconnection 17 17
Appropriate Term/Code Not Available 17 17
Device Markings/Labelling Problem 16 16
Material Too Rigid or Stiff 16 16
Inability to Irrigate 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2274 2285
Skin Infection 2083 2219
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1138 1190
Unspecified Infection 593 593
Foreign Body In Patient 495 495
Insufficient Information 411 417
No Consequences Or Impact To Patient 290 290
No Code Available 290 290
Ulcer 194 194
Pneumothorax 181 183
No Known Impact Or Consequence To Patient 167 174
Bowel Perforation 151 151
Peritonitis 145 145
Stomach Ulceration 140 140
Hemorrhage/Bleeding 122 122
Post Operative Wound Infection 113 113
Pain 91 91
Abscess 83 83
Perforation 82 83
Pneumonia 77 77
Aspiration Pneumonitis 74 74
Sepsis 64 64
Skin Inflammation/ Irritation 59 59
Gastrointestinal Hemorrhage 59 60
Vomiting 57 57
Death 57 57
Pressure Sores 57 58
Tissue Breakdown 56 56
Abdominal Pain 55 55
Discomfort 54 54
Aspiration/Inhalation 47 47
Obstruction/Occlusion 45 45
Failure of Implant 39 46
Laceration(s) 34 34
No Patient Involvement 32 32
Granuloma 29 29
Laceration(s) of Esophagus 28 28
Device Embedded In Tissue or Plaque 28 28
Necrosis 27 28
Bacterial Infection 26 27
Fluid Discharge 25 25
Cough 25 25
Unspecified Tissue Injury 25 25
Inflammation 25 25
Skin Tears 25 25
Internal Organ Perforation 24 24
Perforation of Esophagus 23 23
Fistula 22 25
Cellulitis 21 21
Feeding Problem 21 21

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