510(k) K181422
- Device
- SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit
- Applicant
- SPR Therapeutics, Inc.
- 510(k) number
- K181422
- Product code
- NHI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-07-31
- Date received
- 2018-05-31
- Regulation
- 882.5890
- Classification name
- Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kathryn Stager
- Address
- 22901 Millcreek Blvd. Suite 110 Cleveland OH US 44122 44122
FDA Registration Numbers#
- 3005463575
- 2183164
- 1319660
- 1423662
- 3010273872
- 3013404959
- 2183744
- 3004558433
- 2245304
- 3010350335
- 3011035812
- 3023531666
- 1930027
Source Documents#
Other 510(k) Records For Product Code NHI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223306 | SPRINT Peripheral Nerve Stimulation (PNS) System | Spr Therapeutics, Inc. | 2023-01-25 |
| K221425 | Primary Relief | Dyansys, Inc. | 2022-09-13 |
| K220397 | ANSiStim-PP | Dyansys, Inc. | 2022-05-12 |
| K213188 | Primary Relief | Dyansys, Inc. | 2022-01-31 |
| K212859 | First Relief | Dyansys, Inc. | 2021-12-20 |
| K211801 | SPRINT PNS System | Spr Therapeutics, Inc. | 2021-10-13 |
| K202660 | SPRINT PNS System | Spr Therapeutics, Inc. | 2021-01-22 |
| 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 |
| 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 |
| K061166 | DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM | Biowave Corporation | 2006-08-15 |
| K022241 | VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXX | Vertis Neuroscience, Inc. | 2002-09-11 |
| K011702 | VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX | Vertis Neuroscience, Inc. | 2001-12-21 |
Legacy Summary#
summary
FDA Review#
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