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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
  1.  K222846  AMT G-Tube Balloon Gastrostomy Feeding Device
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 1472 1472
2026 840 840

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4204 4438
Break 609 630
Fluid/Blood Leak 408 410
Detachment of Device or Device Component 393 393
Malposition of Device 293 295
Material Rupture 277 277
Obstruction of Flow 260 260
Difficult to Remove 251 251
Unintended Deflation 235 235
Material Puncture/Hole 233 233
Material Split, Cut or Torn 183 183
Leak/Splash 169 169
Device Dislodged or Dislocated 153 154
Material Twisted/Bent 120 120
Material Separation 111 113
Complete Blockage 111 111
Fracture 97 97
Disconnection 86 86
Patient Device Interaction Problem 75 75
Burst Container or Vessel 65 65
Crack 64 64
Migration 62 62
Material Integrity Problem 57 57
Material Fragmentation 56 56
Use of Device Problem 50 50
Deflation Problem 46 48
No Apparent Adverse Event 46 46
Insufficient Information 45 45
Separation Failure 44 44
Inflation Problem 41 41
Stretched 36 38
Unintended Movement 33 33
Improper or Incorrect Procedure or Method 32 32
Entrapment of Device 31 31
Component Missing 24 24
Defective Device 23 24
Device Handling Problem 23 23
Physical Resistance/Sticking 23 23
Therapeutic or Diagnostic Output Failure 22 22
Material Deformation 19 20
Product Quality Problem 19 33
Flushing Problem 19 19
Positioning Problem 19 19
Material Too Rigid or Stiff 19 19
Defective Component 18 26
Expulsion 18 18
Deformation Due to Compressive Stress 18 18
Biocompatibility 18 18
Inability to Irrigate 17 17
Migration or Expulsion of Device 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2706 2719
Skin Infection 2246 2382
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1229 1281
Foreign Body In Patient 526 526
Insufficient Information 465 470
Pneumothorax 165 167
Stomach Ulceration 150 150
Ulcer 148 148
Bowel Perforation 147 147
Unspecified Infection 129 129
Peritonitis 119 119
Hemorrhage/Bleeding 114 114
Pain 90 90
Abscess 76 76
Aspiration Pneumonitis 76 76
Pressure Sores 66 67
Skin Inflammation/ Irritation 66 66
Perforation 63 64
Gastrointestinal Hemorrhage 61 62
Discomfort 54 54
Vomiting 52 52
Sepsis 52 52
No Code Available 51 51
Pneumonia 45 45
Abdominal Pain 44 44
Post Operative Wound Infection 44 44
Tissue Breakdown 41 41
Failure of Implant 39 46
Laceration(s) of Esophagus 37 37
Obstruction/Occlusion 36 36
Aspiration/Inhalation 35 35
Laceration(s) 31 31
Feeding Problem 30 30
Unspecified Tissue Injury 28 28
Fluid Discharge 27 27
Cough 26 26
Skin Tears 26 26
Internal Organ Perforation 26 26
Bacterial Infection 24 25
Granuloma 24 24
Necrosis 24 25
Perforation of Esophagus 21 21
Low Oxygen Saturation 20 20
Device Embedded In Tissue or Plaque 20 20
Cellulitis 20 20
Needle Stick/Puncture 18 18
Cardiac Arrest 18 20
Abdominal Distention 17 17
Fistula 17 20
No Consequences Or Impact To Patient 16 16

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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