# K973234: Midas Touch Electrosurgical Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Iti Medical Technologies, Inc.
- Decided: Oct 27, 1997 after 60 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K903302 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903302: Electrode, Electrosurgery, Megadyne Medical Products, Inc. (1990) Summary page 1.
- K913623: Surgical Electrical Pencil, Aaron Medical, Inc. (1992) Summary page 1.

## Recalls of this device
- Sep 24, 2009 · Not classified · Z-0140-2010: THERE WERE INCONSISTENCIES NOTICED ON THE INSULATION OVERLAP. THE ELECTRODE HAS A LARGE DIAMETER SHAFT THAT TRANSITIONS TO A SMALLER DIAMETER SHAFT. THE 1ST LAYER OF INSULATION WHICH COVERS THE SMALL 
- Aug 29, 2006 · Not classified · Z-0182-2007: Testing conducted by the firm indicates that electrodes identified with certain part numbers may fall out from the electrosurgical pencil or handle presenting the potential for harm or injury to the p

## Indications for use
The ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes are intended for use in standard electrosurgical chucks and pencil type accessories wherever standard monopolar electrosurgical cutting and coagulation electrodes are used.

Source page: https://510kreport.com/device/K973234
Methodology: https://510kreport.com/methodology