• 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 endoscopic tissue approximation device
Regulation Description Endoscope and accessories.
Definition To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
Product CodeOCW
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
APOLLO CORP.
  SUBSTANTIALLY EQUIVALENT 1
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 3
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 13
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
MINI LAP TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 3
OPUSMED INC.
  SUBSTANTIALLY EQUIVALENT 4
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUTURA, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 3
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 6
Detachment of device component 5
Mechanical jam 5
Difficult to open or close 4
Slippage of device or device component 3
Unknown (for use when the device problem is not known) 3
Out-of-box failure 2
Failure to disconnect 2
Bent 2
Device operates differently than expected 2
Device or device fragments location unknown 2
Device, removal of (non-implant) 1
Failure to fire 1
Detachment of device or device component 1
Failure to form staple 1
Device Issue 1
Defective component 1
Component(s), broken 1
Component falling 1
Foreign material 1
Material fragmentation 1
Loose or intermittent connection 1
Mechanical issue 1
Migration of device or device component 1
Needle, separation 1
Replace 1
Total Device Problems 51

-
-