Ion-C— 510(k) K251714

Substantially Equivalent

SurGenTec, LLC

FDA 510(k) clearance K251714 for Ion-C, Substantially Equivalent on 2026-01-16. Applicant: SurGenTec, LLC. Device class: Unclassified.

Clearance details

Applicant: SurGenTec, LLC
Product code: Code MRW
Device class: Unclassified
Advisory panel: Unknown
Date received: 2025-06-03
Decision date: 2026-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

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