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510(k) K251246

Sparrow Ascent by Spark Biomedical, Inc. — Product Code PZR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 25, 2025
Date Received: April 22, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Percutaneous Nerve Stimulator For Opioid Withdrawal
Device Class: Class II
Regulation Number: 882.5896
Review Panel: NE
Submission Type

Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders.