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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accessories, catheter, g-u
Product CodeKNY
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
AVAIL MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
LEOMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
  SUBSTANTIALLY EQUIVALENT 1
PROMEPLA SAM
  SUBSTANTIALLY EQUIVALENT 3
SOLACE THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 7 7
2015 13 13
2016 19 19
2017 21 21
2018 17 17
2019 19 19
2020 36 36
2021 17 17
2022 19 19
2023 13 13
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 97 97
Fracture 15 15
Material Separation 14 14
Device Fell 8 8
Material Fragmentation 8 8
Split 6 6
Detachment of Device or Device Component 6 6
Detachment Of Device Component 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Peeled/Delaminated 5 5
Difficult to Insert 4 4
Physical Resistance 3 3
Device Operates Differently Than Expected 3 3
Material Twisted/Bent 3 3
Material Integrity Problem 2 2
Material Frayed 2 2
Device Contamination with Chemical or Other Material 2 2
Suction Problem 1 1
Structural Problem 1 1
Sharp Edges 1 1
Problem with Sterilization 1 1
Appropriate Term/Code Not Available 1 1
Device Dislodged or Dislocated 1 1
Packaging Problem 1 1
Inflation Problem 1 1
Improper Flow or Infusion 1 1
Material Too Rigid or Stiff 1 1
Incorrect Device Or Component Shipped 1 1
Stretched 1 1
Difficult to Remove 1 1
Deflation Problem 1 1
Unintended Movement 1 1
Difficult to Advance 1 1
Material Disintegration 1 1
Kinked 1 1
Torn Material 1 1
Crack 1 1
Material Split, Cut or Torn 1 1
Flaked 1 1
Defective Device 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 49 49
No Clinical Signs, Symptoms or Conditions 38 38
No Known Impact Or Consequence To Patient 30 30
No Patient Involvement 16 16
Foreign Body In Patient 15 15
Device Embedded In Tissue or Plaque 8 8
Injury 5 5
No Information 4 4
Unspecified Kidney or Urinary Problem 3 3
Pulmonary Edema 3 3
No Code Available 2 2
Hematuria 2 2
Cyst(s) 2 2
Tissue Damage 2 2
Death 1 1
Hypersensitivity/Allergic reaction 1 1
Dysuria 1 1
Necrosis 1 1
Vascular Dissection 1 1
Perforation 1 1
Blood Loss 1 1
Edema 1 1
Abrasion 1 1
Alteration In Body Temperature 1 1
Rash 1 1
Skin Erosion 1 1
Fever 1 1
Swelling 1 1
Laceration(s) 1 1
Pain 1 1
Myocardial Infarction 1 1
Internal Organ Perforation 1 1
Excessive Tear Production 1 1
Urinary Tract Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Gyrus Acmi, Incorporated II May-26-2011
2 Olympus Corporation of the Americas II Aug-14-2023
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