# K193004: Monopolar Cord

- Pathway: 510(k) (Traditional)
- Applicant: New Deantronics Taiwan, Ltd.
- Decided: Dec 19, 2019 after 52 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- 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: 1 generation back to K982749 (1998). 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)
- K982749: Monopolar Foot Control Pencil, Model # SB 112-2, New Deantronics Taiwan, Ltd. (1998) Summary page 4.

## Indications for use
A Monopolar Cord is intended to be used with a compatible electrosurgical generator and an RF electrode to cut tissue and control bleeding by use of high-frequency electrical current.

Source page: https://510kreport.com/device/K193004
Methodology: https://510kreport.com/methodology