Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
The Transurethral Radio Frequency Applicator for Female Stress Urinary Incontinence delivers radio frequency energy to the submucosal tissue of the bladder neck and proximal urethra to treat female stress urinary incontinence due to urethral hypermobility. The RF energy promotes tissue remodeling at the bladder neck, improving urethral support. It is an FDA Class 2 device regulated under 21 CFR 878.4400 in the General and Plastic Surgery specialty, with product code NVJ, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.
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Basic Information
- Product Code
- NVJ
- Device Class
- FDA class 2
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K042132 | NOVASYS TRANSURETHRAL RF SYSTEM | Dec 21, 2004 | Substantially Equivalent | Novasys Medical, Inc. |