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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device applicator, transurethral, radio frequency, for stress urinary incontinence in women
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition Delivery of radio frequency energy to the submucosal tissue of the bladder neck and proximal urethra for the transurethral treatment of female stress urinary incontinence due to hypermobility.
Product CodeNVJ
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
NOVASYS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 24
No Known Device Problem 1
Total Device Problems 25

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 0 0 0 1 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Novasys Medical Inc II Apr-16-2010

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