# K063402: Wick Electrode, Model M019260

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Hearing Systems
- Decided: Dec 11, 2006 after 32 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944314 (1996). 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)
- K944314: Disposable TM-E Cochgtrode - BLSC Part NO. 101123, Bio-Logic Systems Corp. (1996) Summary page 1.

## Indications for use
The IHS TM-Wick Electrode is intended for non-invasive use in acquiring electrocochleography (ECochG) data on patients of all ages, for the purpose of monitoring and recording in the diagnosis of cochlear and auditory disorders. The electrodes are biocompatible, non-sterile, single patient use, disposable devices. The IHS TM-Wick Electrode is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's, or physician's office or other appropriate setting. The anatomical sites of contact of the IHS TM-Wick Electrode for ECochG testing are the patient's ear canal and tympanic membrane (with the contact objects being a thin, soft, flexible silicone tubing and a cotton wick tip which is pre-soaked in a conductive gel/saline solution). These electrodes will include the precaution statement: Federal law restricts this device to sale by or on the order of a physician. Single patient use only.

Source page: https://510kreport.com/device/K063402
Methodology: https://510kreport.com/methodology