esolution® Esophageal Retractor
K-Number: K243233 · 2024-11-09
ApplicantS4 Medical Corp.
Decision Date2024-11-09
Product CodeQXU
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
esolution® Esophageal Retractor is a medical device manufactured by S4 Medical Corp.. It received FDA 510(k) clearance on 2024-11-09 under approval number K243233. The device is classified under product code QXU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the esolution® Esophageal Retractor?
esolution® Esophageal Retractor is a medical device that received FDA 510(k) clearance on 2024-11-09. It is manufactured by S4 Medical Corp.. The 510(k) number is K243233.
When was esolution® Esophageal Retractor approved by the FDA?
esolution® Esophageal Retractor received FDA 510(k) clearance on 2024-11-09, under approval number K243233.
What company makes esolution® Esophageal Retractor?
esolution® Esophageal Retractor is manufactured by S4 Medical Corp..
What is the FDA product code for esolution® Esophageal Retractor?
The FDA product code for esolution® Esophageal Retractor is QXU.
Other Devices by S4 Medical Corp.
Related Devices (Code: QXU)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.