# 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)

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Mar 28, 2024 after 115 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: 14 generations back to K870028 (1987). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 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.
- K200796: Emprint Ablation System with Thermosphere Technology, Covidien, LLC (2020) Summary page 5.

## Indications for use
The Emprint™ ablation system 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™ ablation system is not intended for use in cardiac procedures. The Emprint™ ablation system overlapping technique is only intended for use in the liver.

Source page: https://510kreport.com/device/K233838
Methodology: https://510kreport.com/methodology