ensoETM Temperature Regulation Device

No FDA recalls found in the data synced 6 Oct 2026.

Full name

ensoETM

De Novo Number

DEN230021 ↗

FDA Product Code

QXV

Device Class

Class II

Regulation

21 CFR Part 870.5720

Advisory Committee

Cardiovascular

FDA Decision

DENG De Novo granted

• EnsoETM

  Class II

  CE/MDD FDA 510(k) K180742 Active Cleared 17 May 2018

• EnsoETM

  Class II

  FDA 510(k) K180244 Active Cleared 28 Feb 2018

• Is the ensoETM designed for repeated use in the same patient, or is it intended as a single-use device per procedure?

  The ensoETM is supplied as a single-use system for each procedure, though the device itself may be reusable under specific conditions outlined by the manufacturer. The labeling and regulatory classification emphasize its use in controlled settings like cardiac catheterization labs, where sterility and procedural integrity are critical. Reuse would require adherence to manufacturer guidelines to ensure safety and functionality.

• What clinical setting is the ensoETM intended for, and does it have any restrictions on use with other equipment like MRI machines?

  The ensoETM is explicitly designed for use in cardiac catheterization labs during cardiac ablation procedures. There are no specified MRI safety restrictions mentioned in the documentation, but its use should always follow manufacturer instructions to avoid interference or safety risks with other equipment. Always verify compatibility with your facility’s protocols.

• How does the ensoETM differ in terms of thermal control compared to other esophageal protection devices, and what makes it suitable for cardiac ablation?

  The ensoETM is engineered to provide precise thermal regulation within the esophagus during cardiac ablation, reducing the risk of thermal injury to surrounding tissues. Unlike other devices, its design focuses on maintaining a controlled temperature environment, ensuring procedural efficacy while minimizing complications. This is critical during ablation, where heat from radiofrequency energy can damage nearby structures.

• What regulatory pathways does the ensoETM follow, and how does its classification impact its use in clinical practice?

  The ensoETM is classified as a Class II medical device under FDA regulations and has received direct clearance via a 510(k) submission (DEN230021) through the Cardiovascular advisory committee. This classification means it undergoes stricter scrutiny than Class I devices but doesn’t require the same rigorous premarket approval (PMA) process as Class III. Clinically, this ensures it meets established safety and performance standards for use in cardiac ablation procedures.

• Are there specific storage or handling requirements for the ensoETM to maintain its functionality and sterility?

  While the exact storage details aren’t specified in the provided data, the manufacturer’s guidelines—referenced in the device description—must be followed to preserve functionality and sterility. Since it’s intended for single-use per procedure, proper packaging and environmental controls (e.g., temperature, humidity) are likely critical to prevent contamination or degradation before use in the catheterization lab.