FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Neuspera Neurostimulation System (NNS)
K Number: K202781
·
Decision Aug 27, 2021
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
23
Applicant Total
2
Review Days
339
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Neuspera Neurostimulation System (NNS)
- K Number
- K202781
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neuspera Medical, Inc.
- Date Received
- September 22, 2020
- Decision Date
- August 27, 2021
- Product Code
- GZF
- 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 |
|---|---|---|---|
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GZF), ordered by most recent decision date.
StimTrial Neuromodulation System
FDA 510(k)
FDA Class 2
·Neurology
TalisMann Neuromodulation System
FDA 510(k)
FDA Class 2
·Neurology
Nalu Neurostimulation System for Peripheral Nerve Stimulation
FDA 510(k)
FDA Class 2
·Neurology
Freedom Peripheral Nerve Stimulator (PNS) System
FDA 510(k)
FDA Class 2
·Neurology
Neuspera Nuity System
FDA 510(k)
FDA Class 2
·Neurology
StimRouter Neuromodulation System
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Neuspera Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K221303 | Neuspera Nuity System | Apr 11, 2023 | Substantially Equivalent |