Neuspera Medical, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Neuspera Medical, Inc.” (first 2021, latest 2023), plus 1 PMA decision, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 340 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 339 |
| 2022 | 0 | — |
| 2023 | 1 | 341 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Neuspera Medical, Inc. took a median 340 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 232 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | 2 | 2 |
| EZW | Stimulator, Electrical, Implantable, For Incontinence | 1 | 0 |
Review panels
Most recent Neuspera Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221303 | Neuspera Nuity System | GZF | 2023-04-11 | 341 |
| K202781 | Neuspera Neurostimulation System (NNS) | GZF | 2021-08-27 | 339 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P240031 | PMA | Neuspera Sacral Neuromodulation System | 2025-06-17 |
Recalls
openFDA lists no recalls under a recalling firm named Neuspera Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Neuspera Medical, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT07247136: Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System (Recruiting, started 2025-11-19)
- NCT07144813: Post-Approval Study of the Neuspera Sacral Neuromodulation System (Recruiting, started 2025-09-03)
- NCT04232696: Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI) (Active not recruiting, started 2019-12-13)
- NCT03643380: Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans With Urinary Incontinence (Completed, started 2017-08-17)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Neuspera Medical, Inc. (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via EZW)
Frequently asked questions
How many FDA 510(k) clearances are listed under Neuspera Medical, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Neuspera Medical, Inc.” (first 2021, latest 2023), plus 1 PMA decision, across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Neuspera Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neuspera Medical, Inc. is 340 days.
Which FDA product codes appear under Neuspera Medical, Inc.?
The most frequent FDA product codes under this applicant name are GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief), 2); EZW (Stimulator, Electrical, Implantable, For Incontinence, 1).
Next steps
- See all 2 Neuspera Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZF, Neuspera Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.