# K081647: Electrosurgical Pencil with Ptfe Coated & Uncoated Electrode Tips

- Pathway: 510(k) (Traditional)
- Applicant: Xodus Medical, Inc.
- Decided: Aug 12, 2008 after 61 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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 1.

## Most influential descendants
- K230621: LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes (2023), 0 descendants of its own

## Indications for use
The intended use for this device is to conduct monopolar electrosurgical energy from an electrosurgical unit (ESU), to an electrosurgical electrode consequently to the intended tissue to be cut and/or coagulated.

Source page: https://510kreport.com/device/K081647
Methodology: https://510kreport.com/methodology