Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 device, cystometric, hydraulic
Regulation Description Urodynamics measurement system.
Product CodeFEN
Regulation Number 876.1620
Device Class 2


Premarket Reviews
ManufacturerDecision
SRS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 3 3
2023 3 3
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 1 1
Display or Visual Feedback Problem 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Hemorrhage/Blood Loss/Bleeding 2 2
Insufficient Information 2 2
Abrasion 1 1
Discomfort 1 1
Anxiety 1 1

-
-