FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Neuspera Nuity System
K Number: K221303
·
Decision Apr 11, 2023
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
23
Applicant Total
2
Review Days
341
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Basic Information
- Device Name
- Neuspera Nuity System
- K Number
- K221303
- 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
- May 5, 2022
- Decision Date
- April 11, 2023
- 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.
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StimRouter Neuromodulation System
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Neuspera Neurostimulation System (NNS)
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Neuspera Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K202781 | Neuspera Neurostimulation System (NNS) | Aug 27, 2021 | Substantially Equivalent |