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.
| Device Type ID | 5786 |
| Device Name | Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women |
| Physical State | Consists Of Radio Frequency Probe And Generator And Accessories. |
| Technical Method | Functions Within A System. |
| Target Area | Bladder Neck And Proximal Urethra |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NVJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5786 |
| Device | Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women |
| Product Code | NVJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| CFR Regulation Number | 878.4400 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 1 |