# K965054: Pencil

- Pathway: 510(k) (Traditional)
- Applicant: Megadyne Medical Products, Inc.
- Decided: Jan 24, 1997 after 37 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MegaDyne Medical Products, Inc pencils and electrodes: named in the summary without a submission number
- (no number) Valleylab pencils and electrodes: named in the summary without a submission number
- (no number) Conmed pencils and electrodes: named in the summary without a submission number
- (no number) E&M Engineering pencils: named in the summary without a submission number

## Most influential descendants
- K192542: Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde (2020), 5 descendants of its own
- 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
- K081647: Electrosurgical Pencil with Ptfe Coated & Uncoated Electrode Tips (2008), 1 descendant of its own
- K251108: Erbe ESU Model VIO® 3n with Accessories (2025), 0 descendants of its own

## Recalls of this device
- Apr 6, 2006 · Not classified · Z-0779-06: Surgical device packaging may be damaged and may compromise sterility.
- Apr 6, 2006 · Not classified · Z-0778-06: Surgical device packaging may be damaged and may compromise sterility.
- Apr 6, 2006 · Not classified · Z-0780-06: Surgical device packaging may be damaged and may compromise sterility.
- Apr 6, 2006 · Not classified · Z-0781-06: Surgical device packaging may be damaged and may compromise sterility.
- Apr 6, 2006 · Not classified · Z-0783-06: Surgical device packaging may be damaged and may compromise sterility.
- Apr 6, 2006 · Not classified · Z-0782-06: Surgical device packaging may be damaged and may compromise sterility.
- Apr 6, 2006 · Not classified · Z-0785-06: Surgical device packaging may be damaged and may compromise sterility.
- Apr 6, 2006 · Not classified · Z-0784-06: Surgical device packaging may be damaged and may compromise sterility.

## Indications for use
The intended use of this device is to conduct monopolar electrosurgical energy from an electrosurgical unit (ESU) or generator, to an electrosurgical electrode and subsequently to the target tissue. The device is disposable and sold sterile.

Source page: https://510kreport.com/device/K965054
Methodology: https://510kreport.com/methodology