# K230547: PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Apr 27, 2023 after 58 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: 2 generations back to K936304 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103375: Plumepen Integrated Smoke Evacuation Pencil, Medtek Devices, Inc. (2011) Summary page 5.
- K000904: Penadapt 10, Buffalo Filter Co., Inc. (2000) Summary page 5.

## Most influential descendants
- K260466: Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) (2026), 0 descendants of its own

## Indications for use
The SnapEvac and PenAdapt is an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or blade exposed. This device is considered an accessory to an electrosurgical unit (ESU). SnapEvac and PenAdapt removes surgical smoke during surgical procedures that use ESU for cutting and cauterizing. This device is used in conjunction with a suction (vacuum) source. Contraindications: This device should not be used for microsurgery. The PlumePen® Elite, PlumePen® Ultra, and PlumePen® Pro is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Indicated for use to remove smoke plume from the surgical site and to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the target tissue for the desired surgical effect.

Source page: https://510kreport.com/device/K230547
Methodology: https://510kreport.com/methodology