• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device endoscopic cytology brush
Regulation Description Endoscope and accessories.
Definition To collect cells for cytological evaluation.
Product CodeFDX
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 13 13
2021 19 19
2022 17 17
2023 17 17
2024 20 22
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 44 44
Adverse Event Without Identified Device or Use Problem 18 20
Break 16 16
Mechanical Problem 7 7
Material Deformation 5 5
Retraction Problem 3 3
Material Twisted/Bent 3 3
Device Contaminated During Manufacture or Shipping 3 3
Material Fragmentation 3 3
Activation Problem 2 2
Material Separation 2 2
Contamination /Decontamination Problem 1 1
Unsealed Device Packaging 1 1
Difficult to Open or Close 1 1
Use of Device Problem 1 1
Difficult or Delayed Separation 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 47 47
Foreign Body In Patient 16 16
Insufficient Information 6 6
Hemorrhage/Bleeding 5 5
No Consequences Or Impact To Patient 4 4
Pneumothorax 4 6
Bronchial Hemorrhage 3 3
Pancreatitis 2 2
No Known Impact Or Consequence To Patient 2 2
Hypoxia 1 1
Cardiac Arrest 1 1
Device Embedded In Tissue or Plaque 1 1
No Code Available 1 1
Fever 1 1
Perforation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hobbs Medical, Inc. II Oct-07-2022
2 Hobbs Medical, Inc. II Mar-02-2022
-
-