# K030819: Plasmajet System

- Pathway: 510(k) (Traditional)
- Applicant: Plasma Surgical, Ltd.
- Decided: Aug 5, 2004 after 510 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 K894762 (1989). 5 ancestors in all.
17 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871435: Bard Ems System 6000 E.S.U., C.R. Bard, Inc. (1987) Summary page 1.
- K904545: Force Gsu TM System and Force Gsu TM Handset, Valleylab, Inc. (1990) Summary page 1.
- K963189: Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and Accessories, Erbe USA, Inc. (1996) Summary page 1.

## Most influential descendants
- K090586: Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable Handpiece Cable (GS807-RC) (2009), 16 descendants of its own
- 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

## Indications for use
The PlasmaJetTM System is a neutral plasma coagulator that is designed for coagulation in open surgery and laparoscopic surgery.

Source page: https://510kreport.com/device/K030819
Methodology: https://510kreport.com/methodology