# K090586: Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable Handpiece Cable (GS807-RC)

- Pathway: 510(k) (Traditional)
- Applicant: Bovie Medical
- Decided: Aug 7, 2009 after 156 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: 3 generations back to K894762 (1989). 7 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972267: Helica TC, Tenerco, Inc. (1999) Summary page 1.
- K030819: Plasmajet System, Plasma Surgical, Ltd. (2004) Summary page 1.

## Most influential descendants
- K112233: Bovie J-Plasma Handpiece with Retractable Cutting Blade (2012), 14 descendants of its own
- K151325: Bovie J-Plasma Handpiece (2015), 13 descendants of its own
- K152570: Bovie J-Plasma Precise 360 Handpiece (2015), 12 descendants of its own
- K142975: Bovie Ultimate High Frequency Electrosurgical Generator (2014), 12 descendants of its own
- K170188: Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator (2017), 11 descendants of its own

## Indications for use
The Bovie ICON GS system is an electrosurgical device that utilizes Helium gas for the coagulation of soft tissues during open soft tissue surgery.

Source page: https://510kreport.com/device/K090586
Methodology: https://510kreport.com/methodology