NeurAxis IB-Stim (01-1020)— 510(k) K252024

Substantially Equivalent

Neuraxis

FDA 510(k) clearance K252024 for NeurAxis IB-Stim (01-1020), Substantially Equivalent on 2025-10-16. Applicant: Neuraxis.

Clearance details

Applicant: Neuraxis
Product code: Code QHH
Advisory panel: Gastroenterology, Urology
Date received: 2025-06-30
Decision date: 2025-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmel, IN, US

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