K180742 is an FDA 510(k) clearance for the EnsoETM. This device is classified as a Esophageal Thermal Regulation And Gastric Suctioning Device (Class II - Special Controls, product code PLA).
Submitted by Advanced Cooling Therapy, Inc. D/B/A Attune Medical (Chicago, US). The FDA issued a Cleared decision on May 17, 2018, 56 days after receiving the submission on March 22, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5910. 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) Number | K180742 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 2018 |
| Decision Date | May 17, 2018 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PLA - Esophageal Thermal Regulation And Gastric Suctioning Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5910 |
| Definition | The Device Is Used To Control A Patient's Temperature, While Simultaneously Maintaining Access To The Stomach To Allow Gastric Decompression And Drainage. |