# K193232: Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology

- Pathway: 510(k) (Special)
- Applicant: Covidien, LLC
- Decided: Feb 13, 2020 after 80 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.
4 later devices descend from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133821: Emprint Ablation System, Covidien, LLC (2014) Summary page 5.
- K163105: Emprint Ablation System, Covidien, LLC (2016) Summary page 5.
- K171358: Emprint SX Ablation Platform and Accessories, Coviden, LLC (2017) Summary page 5.

## Most influential descendants
- K200796: Emprint Ablation System with Thermosphere Technology (2020), 3 descendants of its own
- K240480: IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327) (2024), 0 descendants of its own
- K240784: Temperature Sensor Probe  (ABL-18TP20) (2024), 0 descendants of its own
- K233838: Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien™ Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien™ Remote Temperature Probe (RTP20); Covidien™ Remote Temperature Probe, Bulk (RTP20B) (2024), 0 descendants of its own

## Indications for use
The Emprint™ Ablation System is intended for use in percutaneous, laparoscopic, endoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors. The EmprintTM Ablation System is not intended for use in cardiac procedures. 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 nonresectable liver tumors. The Emprint™ SX Ablation Platform is not intended for use in cardiac procedures. The system’s optional, 3-D 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 ablation zone relative to the position of the antenna is displayed on the enhanced ultrasound image.

Source page: https://510kreport.com/device/K193232
Methodology: https://510kreport.com/methodology