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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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4000 4234
Break 507 528
Detachment of Device or Device Component 378 378
Fluid/Blood Leak 365 367
Malposition of Device 245 247
Obstruction of Flow 239 239
Material Rupture 222 222
Difficult to Remove 221 221
Unintended Deflation 214 214
Material Puncture/Hole 163 163
Material Split, Cut or Torn 156 156
Device Dislodged or Dislocated 129 130
Leak/Splash 120 120
Material Twisted/Bent 94 94
Material Separation 91 93
Fracture 76 76
Disconnection 75 75
Patient Device Interaction Problem 67 67
Complete Blockage 61 61
Burst Container or Vessel 59 59
Migration 57 57
Material Integrity Problem 53 53
Crack 51 51
Material Fragmentation 51 51
Deflation Problem 44 46
Separation Failure 40 40
No Apparent Adverse Event 39 39
Inflation Problem 39 39
Insufficient Information 38 38
Use of Device Problem 36 36
Stretched 32 34
Entrapment of Device 25 25
Unintended Movement 24 24
Defective Device 22 23
Device Handling Problem 22 22
Improper or Incorrect Procedure or Method 20 20
Component Missing 20 20
Positioning Problem 18 18
Biocompatibility 18 18
Product Quality Problem 17 31
Material Too Rigid or Stiff 16 16
Inability to Irrigate 16 16
Decrease in Pressure 15 15
Physical Resistance/Sticking 15 15
Misconnection 15 15
Appropriate Term/Code Not Available 15 15
Device Markings/Labelling Problem 14 14
Nonstandard Device 14 14
Defective Component 14 22
Material Deformation 13 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2322 2335
Skin Infection 2144 2280
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1169 1221
Foreign Body In Patient 464 464
Insufficient Information 402 407
Pneumothorax 149 151
Stomach Ulceration 143 143
Bowel Perforation 142 142
Ulcer 138 138
Unspecified Infection 121 121
Peritonitis 116 116
Hemorrhage/Bleeding 96 96
Aspiration Pneumonitis 75 75
Pain 74 74
Abscess 73 73
Skin Inflammation/ Irritation 63 63
Perforation 61 62
Gastrointestinal Hemorrhage 59 60
Pressure Sores 53 54
Sepsis 51 51
No Code Available 51 51
Discomfort 48 48
Vomiting 46 46
Pneumonia 44 44
Post Operative Wound Infection 43 43
Abdominal Pain 41 41
Tissue Breakdown 40 40
Failure of Implant 39 46
Obstruction/Occlusion 33 33
Aspiration/Inhalation 31 31
Laceration(s) 29 29
Laceration(s) of Esophagus 27 27
Cough 25 25
Fluid Discharge 24 24
Internal Organ Perforation 24 24
Skin Tears 24 24
Unspecified Tissue Injury 24 24
Necrosis 22 23
Granuloma 21 21
Device Embedded In Tissue or Plaque 20 20
Feeding Problem 20 20
Bacterial Infection 20 21
Perforation of Esophagus 18 18
Cellulitis 18 18
Low Oxygen Saturation 18 18
Needle Stick/Puncture 17 17
Abdominal Distention 17 17
No Consequences Or Impact To Patient 16 16
Fistula 16 19
Cardiac Arrest 16 18

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
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