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 retention device, suture
Regulation Description Suture retention device.
Product CodeKGS
Regulation Number 878.4930
Device Class 1

MDR Year MDR Reports MDR Events
2021 1 1
2023 11 12
2024 2 2
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13 14
Delivered as Unsterile Product 2 2
Insufficient Information 1 1
Patient Device Interaction Problem 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Damage to Ligament(s) 5 6
Joint Laxity 4 4
Wound Dehiscence 1 1
Failure of Implant 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Bone Fracture(s) 1 1
Perforation 1 1
Thrombosis/Thrombus 1 1
Loss of Range of Motion 1 1
Discomfort 1 1
Insufficient Information 1 1
Muscle/Tendon Damage 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Drs Vascular, Inc II Aug-15-2025
-
-