510(k) K230796
K230796 is an FDA 510(k) premarket notification submitted by Spark Biomedical, Inc. for the device "Sparrow Ascent". The FDA issued a decision of Substantially Equivalent on June 20, 2023. The device falls under product code PZR (Percutaneous Nerve Stimulator For Opioid Withdrawal), a Class II device regulated under 21 CFR 882.5896. Spark Biomedical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 2023
- Date Received
- March 22, 2023
- 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.