Sparrow Ascent— 510(k) K251246

Substantially Equivalent

Spark Biomedical, Inc.

FDA 510(k) clearance K251246 for Sparrow Ascent, Substantially Equivalent on 2025-08-25. Applicant: Spark Biomedical, Inc..

Clearance details

Applicant: Spark Biomedical, Inc.
Product code: Code PZR
Advisory panel: Neurology
Date received: 2025-04-22
Decision date: 2025-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

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