FDA Product Code
FDA Product Code NHI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5890
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K223306 | SPRINT Peripheral Nerve Stimulation (PNS) System | Spr Therapeutics, Inc. | 2023-01-25 | Traditional | PDF ↗ |
| K221425 | Primary Relief | Dyansys, Inc. | 2022-09-13 | Traditional | PDF ↗ |
| K220397 | ANSiStim-PP | Dyansys, Inc. | 2022-05-12 | Traditional | PDF ↗ |
| K213188 | Primary Relief | Dyansys, Inc. | 2022-01-31 | Traditional | PDF ↗ |
| K212859 | First Relief | Dyansys, Inc. | 2021-12-20 | Traditional | PDF ↗ |
| K211801 | SPRINT PNS System | Spr Therapeutics, Inc. | 2021-10-13 | Traditional | PDF ↗ |
| K202660 | SPRINT PNS System | Spr Therapeutics, Inc. | 2021-01-22 | Traditional | PDF ↗ |
| K181422 | SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit | Spr Therapeutics, Inc. | 2018-07-31 | Traditional | PDF ↗ |
| K170902 | Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit | Spr Therapeutics, LLC | 2017-06-26 | Traditional | PDF ↗ |
| K161154 | Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs | Spr Therapeutics, LLC | 2016-07-23 | Traditional | PDF ↗ |
| K061166 | DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM | Biowave Corporation | 2006-08-15 | Traditional | PDF ↗ |
| K022241 | VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXX | Vertis Neuroscience, Inc. | 2002-09-11 | Traditional | PDF ↗ |
| K011702 | VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX | Vertis Neuroscience, Inc. | 2001-12-21 | Traditional | PDF ↗ |
Product code NHI · Class II · Neurology. Data: openFDA.