• 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 unit, cryosurgical, accessories
Regulation Description Cryosurgical unit and accessories.
Product CodeGEH
Regulation Number 878.4350
Device Class 2


Premarket Reviews
ManufacturerDecision
ARBEL MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 6
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BRYMILL CORP.
  SUBSTANTIALLY EQUIVALENT 1
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 3
CRYOCATH TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CRYOGEN, INC.
  SUBSTANTIALLY EQUIVALENT 2
CRYOSURGERY, INC.
  SUBSTANTIALLY EQUIVALENT 3
CSA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 8
ELLMAN INT'L INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDOCARE, INC.
  SUBSTANTIALLY EQUIVALENT 13
ERBE ELEKTROMEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 3
ETGAR GROUP H.M.Y.A. LTD.
  SUBSTANTIALLY EQUIVALENT 1
GALIL MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 23
HEALTHTRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MYOSCIENCE INC
  SUBSTANTIALLY EQUIVALENT 1
ORASURE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
SANARUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPEMBLY CRYOSURGERY
  SUBSTANTIALLY EQUIVALENT 8
VALLEYLAB
  SUBSTANTIALLY EQUIVALENT 2
WALLACH SURGICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 5
WARTNER MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No Known Device Problem 34
Device operates differently than expected 24
Fire 8
No Information 7
Computer software issue 5
Not Applicable 4
Other (for use when an appropriate device code cannot be identified) 3
Device displays error message 2
Computer operating system issue 2
Device handling issue 2
Noise, Audible 2
Gas leak 2
Infusion or flow issue 1
Material integrity issue 1
Operating system becomes non-functional 1
Pressure issue 1
Temperature issue 1
Device disinfection or sterilization issue 1
Fail-safe mechanism issue 1
Free or unrestricted flow 1
Unknown (for use when the device problem is not known) 1
Component missing 1
Bent 1
Blockage within device or device component 1
Burst 1
Insufficient cooling 1
Crack 1
Application interface becomes non-functional or program exits abnormally 1
Difficult to deploy 1
No display or display failure 1
Electrical issue 1
Unintended ejection 1
Fluid leak 1
Improper gas output 1
Hose line rupture 1
Mechanical issue 1
Increase in pressure 1
Difficult to Program or Calibrate 1
Reaction 1
Tip breakage 1
Device inoperable 1
Improper or incorrect procedure or method 1
Total Device Problems 125

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 1 1 1 3 1 3 1 1 3 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Atricure Inc II Dec-30-2014
2 CSA Medical II Apr-23-2015
3 CSA Medical II Jan-07-2015
4 Cooper Surgical, Inc. II Oct-29-2009
5 CooperSurgical, Inc. II Apr-16-2015
6 Endocare, Division Of Healthtronics II Dec-13-2010
7 Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc. II Apr-16-2010
8 Galil Medical II Dec-29-2010
9 Galil Medical II Sep-03-2008
10 Galil Medical, Inc. II Aug-23-2012
11 Galil Medical, Inc. II May-16-2012
12 Galil Medical, Inc. II Feb-03-2011
13 Healthtronics, Inc. II Feb-15-2013
14 Healthtronics, Inc. II Mar-21-2012
15 Wallach Surgical Devices, Inc. II Jul-11-2007

-
-