ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
510(k) K180047
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK180047 | Date8 Nov 2018 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FLL
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
The ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System is a device designed for real-time esophageal temperature monitoring. It comprises the ESOTEST MULTI Monitor, ESOTEST MULTI Probe, and patient cable, with the probe featuring a 7 French body and 11 French sensors (available in configurations of 5 or 7 sensors total).
The system is used during atrial fibrillation ablation procedures to monitor esophageal temperature in real time. It is supplied as a reusable system component setup, with no indication of sterility or single-use status provided in the data. No MRI safety information, storage conditions, or additional authorisations beyond FDA 510(k) clearance under K180047 and product code FLL are specified in the supplied data.
Other devices from Fiab SpA
Questions
AI-generated answers, 28 Sep 2026
What is the ESOTEST MULTI system used for?
The ESOTEST MULTI system is designed for real-time esophageal temperature monitoring during atrial fibrillation ablation procedures, allowing clinicians to track temperature changes in the esophagus to help prevent thermal injury to surrounding tissues.
What components make up the ESOTEST MULTI system?
The system comprises the ESOTEST MULTI Monitor, ESOTEST MULTI Probe, and a patient cable, with the probe featuring a 7 French body and either 5 or 11 French sensors depending on the configuration, allowing for flexible sensor placement during procedures.
Is the ESOTEST MULTI probe sterile or single-use?
The device data does not indicate whether the ESOTEST MULTI probe is sterile or single-use; it is described as part of a reusable system component setup, but no explicit sterility or reuse status is provided in the specifications.
What regulatory pathway was used for the ESOTEST MULTI system?
The ESOTEST MULTI system received FDA 510(k) clearance under submission number K180047, with product code FLL, and was determined to be substantially equivalent to a predicate device through a traditional review process.