510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243233Substantially Equivalent

esolution® Esophageal Retractor

S4 Medical Corp, Chagrin Falls OH / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243233 is the FDA 510(k) clearance record for esolution® Esophageal Retractor, a class II device, cleared for S4 Medical Corp. on under FDA product code QXU (Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation). FDA's definition for product code QXU reads: "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...". FDA records list 2 510(k) clearances for S4 Medical Corp., from to . As of , FDA records show no recalls naming K243233.

Clearance record

Decision date
Received
(31 days to decision)
Product code
QXU Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
Regulation
21 CFR 870.5710
Device class
Class II
Review panel
Cardiovascular
Applicant
S4 Medical Corp. 34 S. Main St., Suite 200, Chagrin Falls OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QXU

Trailing 12 months

FDA records hold no clearances under product code QXU in the trailing twelve months.

FDA records show no clearances under product code QXU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QXU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260