# K203303: Emprint SX Ablation Platform with Thermosphere Technology

- Pathway: 510(k) (Special)
- Applicant: Covidien, LLC
- Decided: Dec 17, 2020 after 38 days
- Product code: NEY (System, Ablation, Microwave And 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: 12 generations back to K870028 (1987). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171358: Emprint SX Ablation Platform and Accessories, Coviden, LLC (2017) Summary page 4.

## Indications for use
The Emprint™ SX Ablation Platform with Thermosphere™ Technology is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The Emprint™ SX Ablation Platform is not intended for use in cardiac procedures. The system’s optional 3D navigation feature assists in the placement of the Emprint™ SX Navigation Antenna with Thermosphere™ Technology using real-time image guidance during intraoperative and laparoscopic ablation procedures. The navigation feature enhances the output of a compatible medical ultrasound imaging system and displays an image of the antenna and its predicted trajectory on a computer monitor. The size and shape of the predicted zone relative to the position of the antenna are displayed on the enhanced ultrasound image.

Source page: https://510kreport.com/device/K203303
Methodology: https://510kreport.com/methodology