Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
An Electrosurgical Radiofrequency System for Female Stress Urinary Incontinence is a transvaginal or laparoscopic device that delivers radiofrequency energy to female pelvic tissue to cause controlled thermal shrinkage and stabilization of tissue, intended to treat stress urinary incontinence. It is FDA Class 2, requiring 510(k) clearance, with product code MUK under 21 CFR 878.4400 in the General and Plastic Surgery specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- MUK
- Device Class
- FDA class 2
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K020952 | SURX RF SYSTEM | May 30, 2002 | Substantially Equivalent | Surx, Inc. |
| K020126 | MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM) | Mar 15, 2002 | Substantially Equivalent | Surx, Inc. |
| K011190 | SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM) | Jan 08, 2002 | Substantially Equivalent | Surx, Inc. |