NVJ — Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women Class II
Classification Details
- Product Code
- NVJ
- Device Class
- Class II
- Regulation Number
- 878.4400
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K042132 | novasys medical | NOVASYS TRANSURETHRAL RF SYSTEM | December 21, 2004 |