Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women

Product Code: NVJ

General & Plastic Surgery Microwave Diathermy Machines

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.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 878.4400


Radiation TypeMicrowave EMF
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as NVJ

5786Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In WomenElectrosurgical Cutting And Coagulation Device And Accessories.

Total Product Life Cycle (TPLC) Devices

5786Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In WomenElectrosurgical Cutting And Coagulation Device And Accessories.

Pre-market Notifications for NVJ

K042132NOVASYS TRANSURETHRAL RF SYSTEMNOVASYS MEDICAL, INC.

Maude Adverse Events

LYRETTEVERATHON MEDICAL2014-05-06
LYRETTENOVASYS MEDICAL2014-02-04
LYRETTENOVASYS MEDICAL2013-11-15
RENESSA RF SYSTEMNOVASYS MEDICAL2011-05-26
RENESSA RF SYSTEMNOVASYS MEDICAL2011-01-25
RENESSA RF SYSTEMNOVASYS MEDICAL2010-06-03
RENESSA RF SYSTEMNOVASYS MEDICAL2010-03-01
RENESSA RF SYSTEMNOVASYS MEDICAL2010-01-12
RENESSA RF SYSTEMNOVASYS MEDICAL2010-01-12
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
RENESSA RF SYSTEMNOVASYS MEDICAL2009-12-24
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