K201873 is an FDA 510(k) clearance for the Sparrow Therapy System. This device is classified as a Percutaneous Nerve Stimulator For Opioid Withdrawal (Class II - Special Controls, product code PZR).
Submitted by Spark Biomedical, Inc. (Dallas, US). The FDA issued a Cleared decision on January 2, 2021, 179 days after receiving the submission on July 7, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5896. Stimulate Nerve Branches To Aid In The Reduction Of Symptoms Associated With Substance Use Disorders..
| 510(k) Number | K201873 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2020 |
| Decision Date | January 02, 2021 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | PZR - Percutaneous Nerve Stimulator For Opioid Withdrawal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5896 |
| Definition | Stimulate Nerve Branches To Aid In The Reduction Of Symptoms Associated With Substance Use Disorders. |