Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
Medical specialty
General, Plastic Surgery
Device class
2
Regulation number
878.4400
Review panel
SU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.