# DEN230021: ensoETM

- Pathway: De Novo (Direct)
- Applicant: Advanced Cooling Therapy, Inc. D/B/A Attune Medical
- Decided: Sep 13, 2023 after 167 days
- Product code: QXV (Temperature Regulation Device For Esophageal Protection During Cardiac Ablation)
- Device class: 2
- Regulation: 21 CFR 870.5720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The ensoETM is a thermal regulating device, intended to: 1. connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature, 2. connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures, and 3. provide gastric decompression and suctioning. The ensoETM is a thermal regulating device, intended to: 1. connect to a Gentherm/Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient temperature, 2. connect to a Gentherm/Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures, and 3. provide gastric decompression and suctioning.

Source page: https://510kreport.com/device/DEN230021
Methodology: https://510kreport.com/methodology