MUK — Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue Class II
FDA product code MUK covers "Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue", a Class II medical device regulated under 21 CFR 878.4400. Submissions are reviewed by the General, Plastic Surgery panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MUK
- Device Class
- Class II
- Regulation Number
- 878.4400
- Submission Type
- Review Panel
- GU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K020952 | surx | SURX RF SYSTEM | May 30, 2002 |
| K020126 | surx | MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSO | March 15, 2002 |
| K011190 | surx | SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SY | January 8, 2002 |