# K200796: Emprint Ablation System with Thermosphere Technology

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Aug 26, 2020 after 153 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: 13 generations back to K870028 (1987). 45 ancestors in all.
3 later devices descend from it; 3 cite 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)
- K193232: Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology, Covidien, LLC (2020) Summary page 5.

## Most influential descendants
- 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.

Source page: https://510kreport.com/device/K200796
Methodology: https://510kreport.com/methodology