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 the device name listed in this FDA 510(k) record. The listed applicant is S4 Medical Corp.. It received FDA 510(k) clearance on 2024-11-09 under 510(k) 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. The listed applicant is S4 Medical Corp.. The 510(k) number is K243233.
When did esolution® Esophageal Retractor receive FDA 510(k) clearance?
esolution® Esophageal Retractor received FDA 510(k) clearance on 2024-11-09, under 510(k) number K243233.
Who is the listed applicant for esolution® Esophageal Retractor?
The FDA 510(k) record lists S4 Medical Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for esolution® Esophageal Retractor?
The FDA product code for esolution® Esophageal Retractor is 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.