# K042132: Novasys Transurethral RF System

- Pathway: 510(k) (Traditional)
- Applicant: Novasys Medical, Inc.
- Decided: Dec 21, 2004 after 134 days
- Product code: NVJ (Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K943450 (1995). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001150: Electrosurgical Electrode Family, Model 20-2 Needle Balloon Catheter, Model 40-4 Needle Balloon Catheter, Model 60-6 Nee, Novasys Medical, Inc. (2000) Summary page 6.
- K013730: Ariel Radio Frequency (RF) Electrosurgical Control Module and Accessories, Novasys Medical, Inc. (2002) Summary page 6.
- K020952: Surx RF System, Surx, Inc. (2002) Summary page 6.

## Recalls of this device
- Jul 27, 2009 · Not classified · Z-1404-2010: Instructions for Use (IFU) revision-- Because of complaints received by the firm of worsened stress incontinence symptoms 3-4 weeks after treatment, the instructions for use were revised to emphasize 

## Indications for use
The Novasys Transurethral RF System is indicated for the transurethral treatment of female stress urinary incontinence due to hypermobility in women who have failed conservative treatment and who are not candidates for surgical therapy.

Source page: https://510kreport.com/device/K042132
Methodology: https://510kreport.com/methodology