PLA

Esophageal Thermal Regulation And Gastric Suctioning Device

Product code

PLA

Device name

Esophageal Thermal Regulation And Gastric Suctioning Device

Device class

Class 2

21 CFR

21 CFR 870.5910

Medical specialty

Cardiovascular

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

9 (all years; only the last 3 years are listed here)

FDA classification definition

The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-10-30.

2 summaries are archived here for direct download.