# K133821: Emprint Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Apr 28, 2014 after 133 days
- Product code: NEY (System, Ablation, Microwave And Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K870028 (1987). 41 ancestors in all.
29 later devices descend from it; 8 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072687: Valleylab Microwave Ablation Generator, Covidien Lp, Formerly Know AS Valleylab, A Divison (2008) Summary page 1.
- K113237: Certus 140 2.45GHZ Ablation System, Neuwave Medical, Inc. (2012) Summary page 1.

## Most influential descendants
- K163105: Emprint Ablation System (2016), 13 descendants of its own
- K183153: Microwave Ablation System (2019), 9 descendants of its own
- K171358: Emprint SX Ablation Platform and Accessories (2017), 6 descendants of its own
- K201265: Disposable Microwave Therapeutic Antennas (2021), 4 descendants of its own
- K201262: Microwave Therapeutic System (2021), 4 descendants of its own

## Recalls of this device
- Aug 7, 2017 · Class II · Z-0560-2018: 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.
- Aug 7, 2017 · Class II · Z-0561-2018: 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.
- Aug 7, 2017 · Class II · Z-0556-2018: 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.
- Aug 7, 2017 · Class II · Z-0557-2018: 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.
- Aug 7, 2017 · Class II · Z-0558-2018: 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.
- Aug 7, 2017 · Class II · Z-0559-2018: 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.
- Feb 23, 2016 · Class II · Z-1187-2016: Medtronic is voluntarily recalling specific item codes and production lots of Covidien Emprint" Percutaneous Antenna with Thermosphere" Technology due to the potential for the generator to shut down i

## Indications for use
The Covidien Emprintw 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 Covidien Emprintrm Ablation System is not intended for use in cardiac procedures.

Source page: https://510kreport.com/device/K133821
Methodology: https://510kreport.com/methodology