Axonics, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Axonics, Inc.” (first 1983, latest 1985), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 69 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DGC | Ige, Antigen, Antiserum, Control | 1 | 1 |
| EWO | Audiometer | 1 | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 1 | 1 |
| GWK | Conditioner, Signal, Physiological | 1 | 1 |
| JZT | Fluorometer | 1 | 1 |
Review panels
- Immunology (2)
- Neurology (2)
- Ear, Nose and Throat (1)
Most recent Axonics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K843712 | AUDIT TM V | GWF | 1985-04-05 | 196 |
| K833298 | AUDIT V AX 135 | GWK | 1983-12-01 | 69 |
| K831870 | ALLERGENETICS FLUORO-FAST READER | JZT | 1983-08-12 | 63 |
| K822335 | AUDIT | EWO | 1983-02-07 | 187 |
| K823494 | TOTAL IGE-FAST TEST | DGC | 1983-01-14 | 52 |
Recalls
openFDA lists no recalls under a recalling firm named Axonics, 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 Axonics, Inc. is the lead sponsor of 6 device studies on ClinicalTrials.gov (4 active or recruiting). Most recent:
- NCT07335484: Aquarius Pilot Study to Evaluate the New Axonics Trial System (Recruiting, started 2026-04-30)
- NCT06789406: PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB (Recruiting, started 2025-09-18)
- NCT06511141: Sacral Neuromodulation for Male Overactive Bladder (MOAB) (Recruiting, started 2024-10-22)
- NCT06186765: F15 Recharge Free Axonics SNM System Clinical Study (Active not recruiting, started 2023-12-08)
- NCT03327948: Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt (Completed, started 2017-11-21)
Frequently asked questions
How many FDA 510(k) clearances are listed under Axonics, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Axonics, Inc.” (first 1983, latest 1985), across 5 product codes in 3 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 Axonics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Axonics, Inc. is 69 days.
Which FDA product codes appear under Axonics, Inc.?
The most frequent FDA product codes under this applicant name are DGC (Ige, Antigen, Antiserum, Control, 1); EWO (Audiometer, 1); GWF (Stimulator, Electrical, Evoked Response, 1).
Next steps
- See all 5 Axonics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DGC, Axonics, 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.