NVJ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Medical specialty
- General, Plastic Surgery
- FDA 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.
- Adverse events (MAUDE)
- 2009: 82 · 2010: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NOVASYS TRANSURETHRAL RF SYSTEM (K042132) | Novasys Medical, Inc. | 2004-12-21 |
Track NVJ automatically
Every clearance here is in the API, with alerts when new ones post.