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 catheter (gastric, colonic, etc.), irrigation and aspiration
Regulation Description Gastrointestinal tube and accessories.
Product CodeKDH
Regulation Number 876.5980
Device Class 2

MDR Year MDR Reports MDR Events
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Decrease in Suction 2 2
Complete Blockage 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Abdominal Distention 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
-
-