# K221743: Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Bonss Medical Technology Co., Ltd.
- Decided: Sep 7, 2023 after 449 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Radio Frequency Plasma Surgical Systems are indicated for cutting, resection, vaporization, ablation and coagulation of soft tissues and hemostasis of blood vessels in otorhinolaryngology head and neck surgery procedures. Radio Frequency Plasma Surgical Electrodes are used in combination with the compatible RF or Plasma device for cutting, resection, vaporization, ablation and coagulation of soft tissues and hemostasis of blood vessels in otorhinolaryngology head and neck surgery procedures.

Source page: https://510kreport.com/device/K221743
Methodology: https://510kreport.com/methodology