NVJ — Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women Class II
FDA product code NVJ covers "Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women", a Class II medical device regulated under 21 CFR 878.4400. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
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 |