# K243233: esolution® Esophageal Retractor

- Pathway: 510(k) (Special)
- Applicant: S4 Medical Corp.
- Decided: Nov 9, 2024 after 31 days
- Product code: QXU (Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation)
- Device class: 2
- Regulation: 21 CFR 870.5710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN230006 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230006: esolution, S4 Medical Corp. (2023) Summary page 5.

## Indications for use
The esolution® Esophageal Retractor is indicated for use in patients undergoing percutaneous cardiac catheter ablation of atrial fibrillation to deviate the esophagus away from the ablation energy source and to reduce the risk of ablation-related esophageal injury.

Source page: https://510kreport.com/device/K243233
Methodology: https://510kreport.com/methodology