# K143161: Force FX-8(S), Force FX-8C (S), Force FX-8CA (S)

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: Dec 19, 2014 after 46 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: 1 generation back to K944602 (1995). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944602: Valleylab Force FX, Valleylab, Inc. (1995) Summary page 4.

## Most influential descendants
- K223932: SafeAir combi (SFR-combi-US) (2023), 0 descendants of its own
- K201221: Electrosurgical Generator (2020), 0 descendants of its own

## Indications for use
The Force FX™ Electrosurgical Generator is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting (resecting, dividing, or separating) and coagulating (hemostasis).

Source page: https://510kreport.com/device/K143161
Methodology: https://510kreport.com/methodology