# K033027: Shinmed Various Models of Electro-Surgical Pencils, SW12200, SW12202, SW12300

- Pathway: 510(k) (Traditional)
- Applicant: Shining World Health Care Co., Ltd.
- Decided: Aug 12, 2004 after 321 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 K001270 (2000). 4 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K031085: Gyrus Plasmakinetic Superpulse System (Generator, Accessories), Gyrus Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- K092634: Obs Disposable Electrosurgical Pencils, Models: Obs-DB, Obs-DR, Obs-DF (2009), 1 descendant of its own
- K170369: Disposable Electrosurgical Pencils (2018), 0 descendants of its own

## Indications for use
The Shinmed Various Models of Electro-Surgical pencils, SW12200, SW12202, SW12300 used with a 510K-clearance generator are intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment. The SHINMED Various Models of Electro-Surgical Pencils used with 510k-clearance generator are intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Source page: https://510kreport.com/device/K033027
Methodology: https://510kreport.com/methodology