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 insufflator, endoscopic vessel harvesting
Regulation Description Laparoscopic insufflator.
Definition To provide selected flow rates and pressures of co2 gas to separate tissue planes so the saphenous vein or radial artery can be isolated and ligated.
Product CodeOSV
Regulation Number 884.1730
Device Class 2

MDR Year MDR Reports MDR Events
2021 3 3
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Therapeutic or Diagnostic Output Failure 2 2
Disconnection 1 1
Failure of Device to Self-Test 1 1
Loss of Power 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 3 3
No Clinical Signs, Symptoms or Conditions 2 2

-
-