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510(k) K180742

EnsoETM by Advanced Cooling Therapy, Inc. D/B/A Attune Medical — Product Code PLA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 17, 2018
Date Received: March 22, 2018
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Esophageal Thermal Regulation And Gastric Suctioning Device
Device Class: Class II
Regulation Number: 870.5910
Review Panel: CV
Submission Type

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

Other clearances for product code PLA

K250632 — Arctx Cool Catheter Set (October 30, 2025)
K233357 — EsoCool Thermal Regulation Catheter (June 27, 2024)
K180244 — EnsoETM (February 28, 2018)
K172029 — EnsoETM (January 5, 2018)
K172493 — EnsoETM (October 17, 2017)
K170009 — Esophageal Cooling Device (March 30, 2017)
K152450 — Esophageal Cooling Device (January 15, 2016)
DEN140018 — ESOPHAGEAL COOLING DEVICE (June 23, 2015)