# K163105: Emprint Ablation System

- Pathway: 510(k) (Special)
- Applicant: Covidien, LLC
- Decided: Dec 6, 2016 after 29 days
- Product code: NEY (System, Ablation, Microwave And Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K870028 (1987). 42 ancestors in all.
13 later devices descend from it; 6 cite it directly.
0 of 56 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 4.

## Most influential descendants
- K171358: Emprint SX Ablation Platform and Accessories (2017), 6 descendants of its own
- K193232: Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology (2020), 4 descendants of its own
- K200796: Emprint Ablation System with Thermosphere Technology (2020), 3 descendants of its own
- K200298: ABI Instrument, Creo Electrosurgical System (2021), 2 descendants of its own
- K223138: AB1 Electrosurgical Instrument, Creo Electrosurgical System (2023), 1 descendant of its own

## Recalls of this device
- Nov 15, 2018 · Class II · Z-0625-2019: The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
- Nov 15, 2018 · Class II · Z-0627-2019: The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
- Nov 15, 2018 · Class II · Z-0626-2019: The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

## 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 non-resectable liver tumors. The Emprint Ablation System is not intended for use in cardiac procedures.

Source page: https://510kreport.com/device/K163105
Methodology: https://510kreport.com/methodology