ClearFit Ti Ring 14mm (171750) +4 more— 510(k) K260709

Name: FDA 510(k) clearance K260709
Creator: U.S. Food and Drug Administration
Published: 2026-06-25

Substantially Equivalent

Longeviti Neuro Solutions

FDA 510(k) clearance K260709 for ClearFit Ti Ring 14mm (171750) +4 more, Substantially Equivalent on 2026-06-25. Applicant: Longeviti Neuro Solutions. Device class: 2.

Clearance details

Device name as filed: ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)
Applicant: Longeviti Neuro Solutions
Product code: Code GXN
Device class: Class 2
Regulation: 21 CFR 882.5330
Advisory panel: Neurology
Date received: 2026-03-04
Decision date: 2026-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GXN

product code GXN

Injury: 208
Total: 208

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.