# K213317: ShinEvac Smoke Evacuation Pencil

- Pathway: 510(k) (Traditional)
- Applicant: Shining World Health Care Co., Ltd.
- Decided: Jan 28, 2022 after 116 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.

## Most influential descendants
- K250400: Vigeon Laparoscopic Universal Smoke Evacuator (VG003) (2025), 0 descendants of its own

## Indications for use
The ShinEvac@ Smoke Evacuation Pencil 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 and electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

Source page: https://510kreport.com/device/K213317
Methodology: https://510kreport.com/methodology