DeviceClearance

Product code PLA— Cardiovascular

EnsoETM

Classification name
Esophageal Thermal Regulation And Gastric Suctioning Device
Device class
Class 2
Regulation
21 CFR 870.5910
Advisory panel
Cardiovascular
Total cleared
9
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PLA under 21 CFR 870.5910, via openFDA

Market context for product code PLA

FDA has cleared 9 devices under product code PLA between 2015 and 2025, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PLA

Recent clearances under product code PLA

Data sourced from openFDA. This site is unofficial and independent of the FDA.