PLA
9 FDA 510(k) clearances · Product code
140 daysmedian time to decision
410 days90th percentile
9clearances measured
FDA profile
- Official device name
- Esophageal Thermal Regulation And Gastric Suctioning Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5910
- Medical specialty
- Cardiovascular
- Flags
- Third-party review eligible
- FDA definition
- The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Arctx Cool Catheter Set (K250632) | Arctx Medical | 2025-10-30 |
| EsoCool Thermal Regulation Catheter (K233357) | Nuvaira, Inc. | 2024-06-27 |
| EnsoETM (K180742) | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2018-05-17 |
| EnsoETM (K180244) | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2018-02-28 |
| EnsoETM (K172029) | Attune Medical | 2018-01-05 |
| EnsoETM (K172493) | Attune Medical | 2017-10-17 |
| Esophageal Cooling Device (K170009) | Advanced Cooling Therapy, LLC | 2017-03-30 |
| Esophageal Cooling Device (K152450) | Advanced Cooling Therapy, LLC | 2016-01-15 |
| ESOPHAGEAL COOLING DEVICE (DEN140018) | Advanced Cooling Therapy, LLC | 2015-06-23 |
Track PLA automatically
Every clearance here is in the API, with alerts when new ones post.