Spark Biomedical, Inc.

Medical device manufacturer in Dallas, TX.

3510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K251246Sparrow AscentPZR · Traditional 08/25/2025SE
K230796Sparrow AscentPZR · Traditional 06/20/2023SE
K201873Sparrow Therapy SystemPZR · Traditional 01/02/2021SE

Recalls

RecallProductInitiated
Z-2287-2025 Class IISparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K…Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and… 07/02/2025Open, Classified