# K113771: Signal Gear Urethral Catheter Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Neurovision Medical Products, Inc.
- Decided: Dec 13, 2012 after 357 days
- Product code: FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device)
- Device class: 2
- Regulation: 21 CFR 876.1620
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K874758 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874758: Dantec 13L40 ST. Marks's Pudendal Electrode, Dantec Electronics, Inc. (1988) Summary page 1.

## Recalls of this device
- Apr 8, 2021 · Class II · Z-1968-2021: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
- Apr 8, 2021 · Class II · Z-1970-2021: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.

## Indications for use
The Signal Gear Urethral Catheter Electrode is intended for mucosal surface stimulation/recording from the external urinary sphincter for use in conjunction with urodynamic evaluation of the patient. This device is indicated for use in adults, as well as in pediatric patients ages 2 and older.

Source page: https://510kreport.com/device/K113771
Methodology: https://510kreport.com/methodology