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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
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 1471 1471
2026 265 265

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4074 4308
Break 540 561
Fluid/Blood Leak 383 385
Detachment of Device or Device Component 383 383
Malposition of Device 258 260
Obstruction of Flow 245 245
Material Rupture 241 241
Difficult to Remove 232 232
Unintended Deflation 218 218
Material Puncture/Hole 190 190
Material Split, Cut or Torn 170 170
Leak/Splash 138 138
Device Dislodged or Dislocated 135 136
Material Twisted/Bent 98 98
Material Separation 92 94
Fracture 82 82
Disconnection 79 79
Patient Device Interaction Problem 73 73
Complete Blockage 63 63
Migration 59 59
Burst Container or Vessel 59 59
Material Integrity Problem 53 53
Material Fragmentation 53 53
Crack 53 53
Deflation Problem 45 47
Separation Failure 43 43
Insufficient Information 41 41
No Apparent Adverse Event 41 41
Inflation Problem 39 39
Use of Device Problem 39 39
Stretched 33 35
Entrapment of Device 26 26
Unintended Movement 24 24
Component Missing 24 24
Defective Device 23 24
Device Handling Problem 22 22
Improper or Incorrect Procedure or Method 21 21
Positioning Problem 18 18
Defective Component 18 26
Biocompatibility 18 18
Inability to Irrigate 17 17
Product Quality Problem 17 31
Material Too Rigid or Stiff 16 16
Physical Resistance/Sticking 16 16
Decrease in Pressure 15 15
Misconnection 15 15
Material Deformation 15 16
Appropriate Term/Code Not Available 15 15
Nonstandard Device 15 15
Loose or Intermittent Connection 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2419 2432
Skin Infection 2187 2323
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1189 1241
Foreign Body In Patient 478 478
Insufficient Information 429 434
Pneumothorax 153 155
Stomach Ulceration 143 143
Bowel Perforation 143 143
Ulcer 141 141
Unspecified Infection 123 123
Peritonitis 118 118
Hemorrhage/Bleeding 99 99
Pain 81 81
Aspiration Pneumonitis 75 75
Abscess 74 74
Skin Inflammation/ Irritation 64 64
Pressure Sores 62 63
Perforation 62 63
Gastrointestinal Hemorrhage 60 61
Discomfort 51 51
No Code Available 51 51
Sepsis 51 51
Vomiting 49 49
Pneumonia 45 45
Post Operative Wound Infection 43 43
Abdominal Pain 41 41
Tissue Breakdown 40 40
Failure of Implant 39 46
Laceration(s) of Esophagus 33 33
Obstruction/Occlusion 33 33
Aspiration/Inhalation 31 31
Laceration(s) 30 30
Feeding Problem 29 29
Cough 26 26
Fluid Discharge 26 26
Skin Tears 26 26
Necrosis 24 25
Internal Organ Perforation 24 24
Unspecified Tissue Injury 24 24
Bacterial Infection 22 23
Granuloma 21 21
Device Embedded In Tissue or Plaque 20 20
Perforation of Esophagus 18 18
Needle Stick/Puncture 18 18
Low Oxygen Saturation 18 18
Cellulitis 18 18
Abdominal Distention 17 17
Cardiac Arrest 17 19
No Consequences Or Impact To Patient 16 16
Fistula 16 19

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 Boston Scientific Corporation II Apr-11-2024
9 C.R. Bard Inc I May-20-2025
10 C.R. Bard Inc II Jan-25-2024
11 Cardinal Health 200, LLC II Oct-17-2025
12 Cardinal Health 200, LLC II Sep-26-2024
13 Hollister Incorporated II Mar-26-2021
14 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
15 Wilson-Cook Medical Inc. II Feb-05-2026
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