MUK
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Medical specialty
- General, Plastic Surgery
- FDA definition
- For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence
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| Record | Firm | Date | Builder |
|---|---|---|---|
| SURX RF SYSTEM (K020952) | Surx, Inc. | 2002-05-30 | + Add |
| MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM) (K020126) | Surx, Inc. | 2002-03-15 | + Add |
| SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM) (K011190) | Surx, Inc. | 2002-01-08 | + Add |
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Every clearance here is in the API, with alerts when new ones post.