# K100669: Canady Plasma Electrosurgical Unit Series with Accessory Probes and Blades

- Pathway: 510(k) (Traditional)
- Applicant: Us Medical Innovations, LLC
- Decided: Apr 6, 2011 after 393 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: 4 generations back to K894762 (1989). 13 ancestors in all.
2 later devices descend 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)
- K052035: Canady Plasma Probes, Canady Technology, LLC (2005) Summary page 1.
- K933157: Erbotom Icc 200, Erbe USA, Inc. (1994) Summary page 1.
- K023886: Erbe Vio Esu with Accessories, Model Vio 300 D, Erbe USA, Inc. (2002) Summary page 1.
- K024047: Erbe Vio Apc with Accessories, Erbe USA, Inc. (2003) Summary page 1.
- K013348: Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158, 20132-155, 20132-156, 20132-157, 20132-166, Erbe USA, Inc. (2001)
- K944602: Valleylab Force FX, Valleylab, Inc. (1995) Summary page 1.
- K022856: Bovie Ids-300 High Frequency Electrosurgical Generator, Aaron Medical Industries (2003) Summary page 1.

## Most influential descendants
- K192124: Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories (2019), 1 descendant of its own
- K240297: Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) (2024), 0 descendants of its own

## Indications for use
The Canady Plasma Coagulator devices are intended to provide gas-enhanced coagulation during general surgery procedures. The Canady Plasma Coagulator devices are Argon Plasma Coagulation Unit designed for gas enhanced coagulation when used only with the Canady Plasma Electrosurgery Unit models and compatible monopolar and/or bipolar RF 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/K100669
Methodology: https://510kreport.com/methodology