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510(k) K180244

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2018
Date Received
January 29, 2018
Clearance Type
Special
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 by Advanced Cooling Therapy, Inc. D/B/A Attune Medical

Other clearances for product code PLA

  • K250632 — Arctx Cool Catheter Set (October 30, 2025)
  • K233357 — EsoCool Thermal Regulation Catheter (June 27, 2024)
  • K180742 — EnsoETM (May 17, 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)