Esophageal Thermal Regulation And Gastric Suctioning Device
The Esophageal Thermal Regulation And Gastric Suctioning Device (product code PLA) is a Class 2 cardiovascular device used to control a patient's temperature while simultaneously maintaining access to the stomach for gastric decompression and drainage, regulated under 870.5910. It requires 510(k) clearance and is eligible for third-party review. The device is not flagged as an implant or life-sustaining product.
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Basic Information
- Product Code
- PLA
- Device Class
- FDA class 2
- Regulation Number
- 870.5910
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250632 | Arctx Cool Catheter Set | Oct 30, 2025 | Substantially Equivalent | Arctx Medical |
| K233357 | EsoCool Thermal Regulation Catheter | Jun 27, 2024 | Substantially Equivalent | Nuvaira, Inc. |
| K180742 | EnsoETM | May 17, 2018 | Substantially Equivalent | Advanced Cooling Therapy, Inc. D/B/A Attune Medical |
| K180244 | EnsoETM | Feb 28, 2018 | Substantially Equivalent | Advanced Cooling Therapy, Inc. D/B/A Attune Medical |
| K172029 | EnsoETM | Jan 05, 2018 | Substantially Equivalent | Attune Medical |
| K172493 | EnsoETM | Oct 17, 2017 | Substantially Equivalent | Attune Medical |
| K170009 | Esophageal Cooling Device | Mar 30, 2017 | Substantially Equivalent | Advanced Cooling Therapy, LLC |
| K152450 | Esophageal Cooling Device | Jan 15, 2016 | Substantially Equivalent | Advanced Cooling Therapy, LLC |
| DEN140018 | ESOPHAGEAL COOLING DEVICE | Jun 23, 2015 | Unknown | Advanced Cooling Therapy, LLC |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.