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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
AMB MEDTEC
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
AVANOS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOEHRINGER LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER LABORATORIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  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
RESHAPE LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 4
STANDARD BARIATRICS
  SUBSTANTIALLY EQUIVALENT 2
STANDARD BARIATRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOOLS FOR SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 1655 1681
2022 1650 1666
2023 1863 1871
2024 1344 1577
2025 1472 1472
2026 1044 1044

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4212 4445
Break 536 536
Fluid/Blood Leak 381 381
Detachment of Device or Device Component 366 366
Malposition of Device 282 282
Material Rupture 248 248
Obstruction of Flow 243 243
Difficult to Remove 233 233
Unintended Deflation 229 229
Material Puncture/Hole 225 225
Material Split, Cut or Torn 175 175
Leak/Splash 140 140
Complete Blockage 136 136
Material Twisted/Bent 114 114
Device Dislodged or Dislocated 102 102
Material Separation 98 100
Fracture 90 90
Disconnection 84 84
Patient Device Interaction Problem 71 71
Migration 59 59
Burst Container or Vessel 59 59
Material Fragmentation 52 52
Material Integrity Problem 49 49
Insufficient Device Problem Information 47 47
No Apparent Adverse Event 47 47
Use of Device Problem 45 45
Crack 43 43
Stretched 42 44
Separation Failure 38 38
Deflation Problem 35 35
Inflation Problem 31 31
Unintended Movement 30 30
Improper or Incorrect Procedure or Method 25 25
Device Handling Problem 23 23
Deformation Due to Compressive Stress 22 22
Biocompatibility 18 18
Component Missing 17 17
Material Too Rigid or Stiff 17 17
Expulsion 17 17
Nonstandard Device 16 16
Inability to Irrigate 16 16
Difficult to Advance 16 16
Misconnection 15 15
Decrease in Pressure 15 15
Flushing Problem 15 15
Positioning Problem 15 15
Fitting Problem 14 14
Appropriate Device Problem Term/Code Not Available 13 13
Restricted Flow rate 13 13
Migration or Expulsion of Device 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2816 2829
Skin Infection 2265 2401
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1242 1294
Foreign Body In Patient 533 533
Insufficient Information 487 492
Pneumothorax 167 169
Stomach Ulceration 151 151
Bowel Perforation 149 149
Ulcer 148 148
Unspecified Infection 132 132
Peritonitis 130 130
Hemorrhage/Blood Loss/Bleeding 114 114
Pain 90 90
Abscess 78 78
Aspiration Pneumonitis 77 77
Pressure Sore/Ulcer 68 69
Skin Inflammation/ Irritation 66 66
Perforation 63 64
Gastrointestinal Hemorrhage 61 62
Discomfort 54 54
Vomiting 53 53
Sepsis 52 52
No Code Available 51 51
Pneumonia 45 45
Post Operative Wound Infection 44 44
Abdominal Pain 44 44
Tissue Breakdown 42 42
Failure of Implant 39 46
Obstruction/Occlusion 37 37
Laceration(s) of Esophagus 37 37
Aspiration/Inhalation 35 35
Laceration(s) 31 31
Feeding Problem 30 30
Unspecified Tissue Injury 29 29
Fluid Discharge 27 27
Cough 27 27
Skin Tears 26 26
Internal Organ Perforation 26 26
Granuloma 24 24
Bacterial Infection 24 25
Necrosis 24 25
Perforation of Esophagus 21 21
Device Embedded In Tissue or Plaque 21 21
Cellulitis 21 21
Low Oxygen Saturation 20 20
Pneumoperitoneum 20 20
Cardiac Arrest 18 20
Needle Stick/Puncture 18 18
Abdominal Distention 17 17
Fistula 17 20

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 Jun-05-2026
5 Avanos Medical, Inc. II Jul-23-2024
6 Avanos Medical, Inc. I Mar-01-2024
7 Avanos Medical, Inc. I May-13-2022
8 Avanos Medical, Inc. II Feb-07-2022
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
16 Wilson-Cook Medical Inc. II Feb-05-2026
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