K243233 is an FDA 510(k) clearance for the esolution® Esophageal Retractor. This device is classified as a Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation (Class II - Special Controls, product code QXU).
Submitted by S4 Medical Corp. (Chagrin Falls, US). The FDA issued a Cleared decision on November 9, 2024, 31 days after receiving the submission on October 9, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5710. This Device Is Placed In The Lumen Of The Esophagus To Reduce The Likelihood Of Esophageal Injury Or A Specific Adverse Event During Cardiac Ablation Procedures. The Device Uses Mechanical Means To Deviate The Esophagus Away From The Source Of Ablation Energy.
| 510(k) Number | K243233 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2024 |
| Decision Date | November 09, 2024 |
| Days to Decision | 31 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QXU - Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5710 |
| Definition | This Device Is Placed In The Lumen Of The Esophagus To Reduce The Likelihood Of Esophageal Injury Or A Specific Adverse Event During Cardiac Ablation Procedures. The Device Uses Mechanical Means To Deviate The Esophagus Away From The Source Of Ablation Energy |