esolution® Esophageal Retractor— 510(k) K243233

Name: FDA 510(k) clearance K243233
Creator: U.S. Food and Drug Administration
Published: 2024-11-09

Substantially Equivalent

S4 Medical Corp.

FDA 510(k) clearance K243233 for esolution® Esophageal Retractor, Substantially Equivalent on 2024-11-09. Applicant: S4 Medical Corp.. Device class: 2.

Clearance details

Applicant: S4 Medical Corp.
Product code: Code QXU
Device class: Class 2
Regulation: 21 CFR 870.5710
Advisory panel: Cardiovascular
Date received: 2024-10-09
Decision date: 2024-11-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Chagrin Falls, OH, US

Download summary PDF View on FDA.gov ↗

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