# K192124: Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories

- Pathway: 510(k) (Special)
- Applicant: Us Medical Innovations, LLC
- Decided: Nov 21, 2019 after 107 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: 5 generations back to K894762 (1989). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100669: Canady Plasma Electrosurgical Unit Series with Accessory Probes and Blades, Us Medical Innovations, LLC (2011) Summary page 4.

## Most influential descendants
- K240297: Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) (2024), 0 descendants of its own

## Indications for use
The Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories is intended to provide gas-enhanced coagulation during general surgery procedures. The Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories is designed for gas enhanced coagulation when used only with the Canady Plasma Electrosurgery Unit and compatible monopolar and/or bipolar handpieces. The Canady Electrosurgery Unit Generators are intended to cut and/or coagulate tissue when used with compatible monopolar and/or bipolar RF handpieces. The Canady Electrosurgery Unit Generators are capable of monopolar argon gas enhanced coagulation when used with Canady Plasma Coagulator and probes

Source page: https://510kreport.com/device/K192124
Methodology: https://510kreport.com/methodology