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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Percutaneous Nerve Stimulator For Opioid Withdrawal
510(k) Number K230796
Device Name Sparrow Ascent
Applicant
Spark Biomedical, Inc.
18208 Preston Road, Suite D9-531
Dallas,  TX  75252
Applicant Contact Brent Croft
Correspondent
RQM+
2251 San Diego Avenue, Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison Komiyama
Regulation Number882.5896
Classification Product Code
PZR  
Date Received03/22/2023
Decision Date 06/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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