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 suture kit
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOVN
Regulation Number 878.4830
Device Class 2

MDR Year MDR Reports MDR Events
2015 13 13
2016 1 1
2017 1 1
2018 4 4
2019 4 4
2020 1 1
2021 1 1
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 21 21
Detachment of Device or Device Component 3 3
Disconnection 1 1
Output Problem 1 1
Insufficient Information 1 1
Product Quality Problem 1 1
Nonstandard Device 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 12 12
No Information 6 6
No Known Impact Or Consequence To Patient 4 4
No Code Available 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Foreign Body In Patient 1 1
Insufficient Information 1 1
Discharge 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
-
-