# MUK: Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue

- Device class: 2; regulation: 21 CFR 878.4400; FDA's rule: 510(k) required
- FDA decisions: 3
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2002: 3

## Most-cited predicates
- K011190: Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System) (2002), cited by 2
- K020952: Surx RF System (2002), cited by 1
- K020126: Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx TV System) (2002), cited by 1

Source page: https://510kreport.com/product-code/MUK
Data by year (CSV): https://510kreport.com/product-code/MUK.csv