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510(k) K180742

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

K180742 is an FDA 510(k) premarket notification submitted by Advanced Cooling Therapy, Inc. D/B/A Attune Medical for the device "EnsoETM". The FDA issued a decision of Substantially Equivalent on May 17, 2018. The device falls under product code PLA (Esophageal Thermal Regulation And Gastric Suctioning Device), a Class II device regulated under 21 CFR 870.5910. Advanced Cooling Therapy, Inc. D/B/A Attune Medical has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2018
Date Received
Mar 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 by Advanced Cooling Therapy, Inc. D/B/A Attune Medical

Other clearances for product code PLA

  • K250632 — Arctx Cool Catheter Set (Oct 30, 2025)
  • K233357 — EsoCool Thermal Regulation Catheter (Jun 27, 2024)
  • K180244 — EnsoETM (Feb 28, 2018)
  • K172029 — EnsoETM (Jan 5, 2018)
  • K172493 — EnsoETM (Oct 17, 2017)
  • K170009 — Esophageal Cooling Device (Mar 30, 2017)
  • K152450 — Esophageal Cooling Device (Jan 15, 2016)
  • DEN140018 — ESOPHAGEAL COOLING DEVICE (Jun 23, 2015)

FDA data resources