# Esophageal Thermal Regulation And Gastric Suctioning Device
> **Product code: PLA** · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.5910
## Classification
- **FDA Product Code:** PLA
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 870.5910
- **Review panel:** CV
- **Medical specialty:** Cardiovascular
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage.

## Market data
- **Cleared 510(k) submissions:** 9
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PLA)
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