FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPRINT PNS System
K Number: K240974
·
Decision Apr 14, 2026
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
0
Applicant Total
5
Review Days
734
Basic Information
- Device Name
- SPRINT PNS System
- K Number
- K240974
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Spr Therapeutics, Inc.
- Date Received
- April 10, 2024
- Decision Date
- April 14, 2026
- Product Code
- SCN
- 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 |
|---|---|---|---|
| SCN | Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief | FDA class 2 | Neurology |
Other Clearances by Spr Therapeutics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K181422 | SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit | Jul 31, 2018 | Substantially Equivalent |