• 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 Back To Search Results
Device cutaneous tissue adhesive with mesh
Regulation Description Tissue adhesive with adjunct wound closure device for topical approximation of skin.
Definition For topical application only to hold closed easily approximated skin edges of wounds such as wounds from surgical incisions, including punctures from minimally invasive surgery, and simple thorough cleansed, trauma-induced lacerations. The device may be used in conjunction with, but not in place of, deep dermal sutures.
Product CodeOMD
Regulation Number 878.4011
Device Class 2


Premarket Reviews
ManufacturerDecision
CLOSURE MEDICAL CORP.
  GRANTED 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No code available 144
Reaction 2
Tear, rip or hole in device packaging 1
No Information 1
Failure to Adhere or Bond 1
Material erosion 1
Total Device Problems 150

-
-