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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laparoscopic contraceptive tubal occlusion device
Regulation Description Contraceptive tubal occlusion device (TOD) and introducer.
Definition Call for PMAs to be filed by 12/30/87 (52 FR 36883 (10/1/87))
Product CodeKNH
Regulation Number 884.5380
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
1 1 4 9 12 5 0 2 1 9 1

Device Problems
No Known Device Problem 28
Unsealed device packaging 20
Break 12
No code available 10
Device handling issue 8
Patient-device incompatibility 7
No Information 6
Device operates differently than expected 5
Difficult to remove 4
Migration of device or device component 3
Difficult to insert 2
Failure to deploy 2
Entrapment of device or device component 2
Failure to separate 2
Dislodged or dislocated 2
Expulsion 2
Extrusion 2
Not Applicable 2
Positioning Issue 1
Human-Device Interface Issue 1
Device packaging compromised 1
Detachment of device or device component 1
Device or device fragments location unknown 1
Malposition of device 1
Product quality issue 1
Use of Device Issue 1
Unknown (for use when the device problem is not known) 1
Implant, removal of 1
Implant, repositioning of 1
Cut in material 1
Unintended ejection 1
Detachment of device component 1
Device maintenance issue 1
Mechanical issue 1
Delivered as unsterile product 1
Total Device Problems 136

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 3 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Gyrus Acmi, Incorporated II Jun-26-2015
2 Gyrus Medical, Inc II Aug-19-2014
3 Gyrus Medical, Inc II Mar-13-2014
4 Richard Wolf Medical Instruments Corp. II Nov-06-2014

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