Data / Medical devices / United States / S4 Medical Corp
S4 Medical Corp: FDA-registered device maker in Chagrin Falls, OH, United States, 1 510(k) clearance
S4 Medical Corp is registered with the FDA (registration 3019622578) in Chagrin Falls, OH, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 6, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019622578
- Address
- 549 Washington St Ste 8, Chagrin Falls, OH, United States, 44022
- Owner or operator
- S4 Medical Corp (10082158)
- Roles
- Manufacturer
- First device listed
- June 13, 2024
- Registered through
- 2026
- Brand names listed
- esolution
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation | QXU | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 6, 2023 | DEN230006 | esolution | QXU | Unknown | S4 Medical Corp. | accessdata.fda.gov |
Updated September 6, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.