# DEN230006: esolution

- Pathway: De Novo (Direct)
- Applicant: S4 Medical Corp.
- Decided: Sep 6, 2023 after 225 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K243233: esolution® Esophageal Retractor (2024), 0 descendants of its own

## 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/DEN230006
Methodology: https://510kreport.com/methodology