K211801 is an FDA 510(k) clearance for the SPRINT PNS System. This device is classified as a Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief (Class II - Special Controls, product code NHI).
Submitted by Spr Therapeutics, Inc. (Cleveland, US). The FDA issued a Cleared decision on October 13, 2021, 125 days after receiving the submission on June 10, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890. Percutaneous Electrical Nerve Stimulator (pens) Is A Device Used For The Treatment Of Pain. Unlike The Classified Transcutaneous Electrical Nerve Stimulator That Apply An Electrical Current To Electrodes On A Patient's Skin To Deliver Stimulation, A Pens Uses Electrodes That Are Placed Percutaneously To Deliver Stimulation,.
| 510(k) Number | K211801 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2021 |
| Decision Date | October 13, 2021 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NHI - Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |
| Definition | Percutaneous Electrical Nerve Stimulator (pens) Is A Device Used For The Treatment Of Pain. Unlike The Classified Transcutaneous Electrical Nerve Stimulator That Apply An Electrical Current To Electrodes On A Patient's Skin To Deliver Stimulation, A Pens Uses Electrodes That Are Placed Percutaneously To Deliver Stimulation, |