FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit
K Number: K181422
·
Decision Jul 31, 2018
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
12
Applicant Total
5
Review Days
61
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Basic Information
- Device Name
- SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit
- K Number
- K181422
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spr Therapeutics, Inc.
- Date Received
- May 31, 2018
- Decision Date
- July 31, 2018
- Product Code
- NHI
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NHI | Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NHI), ordered by most recent decision date.
SPRINT Peripheral Nerve Stimulation (PNS) System
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FDA 510(k)
FDA Class 2
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FDA Class 2
·Neurology
Other Clearances by Spr Therapeutics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240974 | SPRINT PNS System | Apr 14, 2026 | Substantially Equivalent |
| K223306 | SPRINT Peripheral Nerve Stimulation (PNS) System | Jan 25, 2023 | Substantially Equivalent |
| K211801 | SPRINT PNS System | Oct 13, 2021 | Substantially Equivalent |
| K202660 | SPRINT PNS System | Jan 22, 2021 | Substantially Equivalent |