MUK · Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
General, Plastic Surgery · 21 CFR 878.4400 · Class 2
Overview
| Product Code | MUK |
|---|---|
| Device Name | Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue |
| 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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K020952 | SURX RF SYSTEM | Surx, Inc. | May 30, 2002 | SESE |
| K020126 | MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM) | Surx, Inc. | Mar 15, 2002 | SESE |
| K011190 | SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM) | Surx, Inc. | Jan 8, 2002 | SESE |
Top Applicants
- Surx, Inc. — 3 clearances
