NVJClass II
Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
21 CFR 878.4400 / General, Plastic Surgery
NVJ is the FDA product code for Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women, a class II device type, regulated under 21 CFR 878.4400. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.
Classification record
- Product code
- NVJ
- Device name
- Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
- 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.
- Regulation
- 21 CFR 878.4400
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 1
Clearances, product code NVJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2004 | 1 |
Applicants with the most clearances
Product code NVJ| Applicant | Clearances |
|---|---|
| Novasys Medical, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code NVJ.
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