Neuspera Nuity System
FDA 510(k) clearance K221303 · decided 2023-04-11
Clearance details
- K-number
- K221303
- Device name
- Neuspera Nuity System
- Applicant
- Neuspera Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-05-05
- Decision date
- 2023-04-11
- Days to decision
- 341 days
- Clearance type
- Traditional
- Product code
- GZF
- Device class
- 2
- Regulation number
- 882.5870
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Neuspera Sacral Neuromodulation System (P240031/S001) | Neuspera Medical, Inc. | 2025-08-15 |
| Neuspera Sacral Neuromodulation System (P240031) | Neuspera Medical, Inc. | 2025-06-17 |