FDA product code MUK: Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
MUK is the FDA product code for electrosurgical radiofrequency system, stress urinary incontinence, female, transvaginal or laparoscopic, pelvic tissue. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under MUK. The average 510(k) review took 130 days (median 66).
Definition
For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence
Classification
| Field | Value |
|---|---|
| Device name | Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every MUK clearance
Top MUK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Surx, Inc. | 3 | 2002-05-30 |
Most recent MUK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K020952 | Surx, Inc. | SURX RF SYSTEM | 2002-05-30 | 66 |
| K020126 | Surx, Inc. | MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM) | 2002-03-15 | 59 |
| K011190 | Surx, Inc. | SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM) | 2002-01-08 | 264 |
Recalls for MUK devices
openFDA lists no recalls for product code MUK.
Frequently asked questions
What is FDA product code MUK?
MUK is the FDA product code for electrosurgical radiofrequency system, stress urinary incontinence, female, transvaginal or laparoscopic, pelvic tissue. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the Gastroenterology and Urology panel.
What device class is MUK?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code MUK?
Across 3 cleared submissions the average was 130 days from receipt to decision (median 66).
Which companies have the most MUK clearances?
Surx, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code MUK
- Run a recall and safety report across every MUK manufacturer
- Watch product code MUK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times