# K011190: Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System)

- Pathway: 510(k) (Traditional)
- Applicant: Surx, Inc.
- Decided: Jan 8, 2002 after 264 days
- Product code: MUK (Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K943450 (1995). 28 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960918: Vidamed Tuna (Transurethral Needle Ablation) System, Vidamed, Inc. (1996) Summary page 1.
- K965199: Tuna 5 Catheter, Vidamed, Inc. (1997) Summary page 1.
- K002583: Tuna (Trans Urethra Needle) Office System, Vidamed, Inc. (2001) Summary page 1.
- K961069: Arthrocare Urologic Multi-Electrode Electrosurgery System, Arthrocare Corp. (1996) Summary page 1.
- K973159: Oratec Interventions Model Ora 40 Electrothermal Generator, Oratec Interventions, Inc. (1997) Summary page 1.
- K964071: Oratec Interventions Model Ora 50 Electrothermal Generator, Oratec Interventions, Inc. (1996) Summary page 1.
- K971532: Arthrocare Electrosurgery System, Arthrocare Corp. (1997) Summary page 1.
- K971797: Laparoscopic Bladder Neck Suspension Kit, Louisville Laboratories, Inc. (1997) Summary page 1.
- K964577: Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse Small Vaginal Electrode (199205), Empi (1997) Summary page 1.

## Most influential descendants
- K020126: Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx TV System) (2002), 2 descendants of its own
- K020952: Surx RF System (2002), 1 descendant of its own
- K042132: Novasys Transurethral RF System (2004), 0 descendants of its own

## Indications for use
The SURx Laparoscopic Probe (LP) Radio Frequency (RF) System is indicated for shrinkage and stabilization of female pelvic tissue for treatment of Type II stress urinary incontinence due to hypermobility in women not eligible for major corrective surgery.

Source page: https://510kreport.com/device/K011190
Methodology: https://510kreport.com/methodology