# K904545: Force Gsu TM System and Force Gsu TM Handset

- Pathway: 510(k) (Traditional)
- Applicant: Valleylab, Inc.
- Decided: Dec 28, 1990 after 85 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
No predicates in its family tree.
18 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030819: Plasmajet System (2004), 17 descendants of its own
- 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

Source page: https://510kreport.com/device/K904545
Methodology: https://510kreport.com/methodology