K243233
- 510(k) number
- K243233
- Device name
- esolution® Esophageal Retractor
- Applicant
- S4 Medical Corp. OH · US
- Product code
- QXU — Esophageal Protection Device For Use In Percutaneous
- Decision date
- 2024-11-09
- Date received
- 2024-10-09
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K243233.pdf
Official FDA record: K243233
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.