NVJClass II
Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
General, Plastic Surgery · 21 CFR 878.4400
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.
MDR events92All time
Recalls1All time
Registered firms0Currently listed
510(k) clearances1All time
Recent MDR events
92 adverse event reports on file
- LYRETTEMay 6, 2014InjuryVerathon Medical3022472-2014-00010
- LYRETTEFeb 4, 2014InjuryNovasys Medical3022472-2014-00002
- LYRETTENov 15, 2013InjuryNovasys Medical3022472-2013-00112
- RENESSA RF SYSTEMMay 26, 2011OtherNovasys Medical3003647794-2011-00088
- RENESSA RF SYSTEMJan 25, 2011OtherNovasys Medical3003647794-2011-00087
- RENESSA RF SYSTEMJun 3, 2010OtherNovasys Medical3003647794-2010-00086
- RENESSA RF SYSTEMMar 1, 2010OtherNovasys Medical3003647794-2010-00085
- RENESSA RF SYSTEMJan 12, 2010OtherNovasys Medical3003647794-2010-00084
- RENESSA RF SYSTEMJan 12, 2010InjuryNovasys Medical3003647794-2010-00083
- RENESSA RF SYSTEMDec 24, 2009InjuryNovasys Medical3003647794-2009-00076
Event type breakdown
Injury50
Other42
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
1 clearances for this product code