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.. Device class: 2.

Clearance details

Applicant
Spark Biomedical, Inc.
Product code
Code PZR
Device class
Class 2
Regulation
21 CFR 882.5896
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Dallas, TX, US
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