510(k) K221303
K221303 is an FDA 510(k) premarket notification submitted by Neuspera Medical, Inc. for the device "Neuspera Nuity System". The FDA issued a decision of Substantially Equivalent on April 11, 2023. The device falls under product code GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5870. Neuspera Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2023
- Date Received
- May 5, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Peripheral Nerve, Implanted (Pain Relief)
- Device Class
- Class II
- Regulation Number
- 882.5870
- Review Panel
- NE
- Submission Type