NVJ · Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
General, Plastic Surgery · 21 CFR 878.4400 · Class 2
Overview
| Product Code | NVJ |
|---|---|
| Device Name | Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K042132 | NOVASYS TRANSURETHRAL RF SYSTEM | Novasys Medical, Inc. | Dec 21, 2004 | SESE |
Top Applicants
- Novasys Medical, Inc. — 1 clearance
