# K192542: Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde

- Pathway: 510(k) (Traditional)
- Applicant: Modern Medical Equipment Manufacturing, Ltd.
- Decided: Jun 16, 2020 after 274 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 K965054 (1997). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965054: Pencil, Megadyne Medical Products, Inc. (1997) Summary page 4.

## Most influential descendants
- K240932: HybridTherm System (2024), 1 descendant of its own
- K213786: CiRX Single use electrosurgical pencil with non-coated and coated electrode (2022), 1 descendant of its own
- K251108: Erbe ESU Model VIO® 3n with Accessories (2025), 0 descendants of its own
- K231405: Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode (2024), 0 descendants of its own
- K232460: Disposable electrosurgical pencil (MD1000) (2023), 0 descendants of its own

## Indications for use
The devices are used to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.

Source page: https://510kreport.com/device/K192542
Methodology: https://510kreport.com/methodology