Data / Medical devices / United States / Neuwave Medical, Inc.
Neuwave Medical, Inc.: FDA-registered device maker in Madison, WI, United States, 6 510(k) clearances
Neuwave Medical, Inc. is registered with the FDA (registration 3008769756) in Madison, WI, United States. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 4, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008769756
- Address
- 3529, 3513 and 3543 Anderson Street, Madison, WI, United States, 53704
- Owner or operator
- NeuWave Medical, Inc. (10034016)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 21, 2016
- Registered through
- 2027
- Brand names listed
- ABLATE-IQ, CT Mounting Brackets, Certus 140 2.45GHz Ablation System, Certus 140 2.45GHz Ablation System with Ablation Confirmation Software, Certus LK Ablation Probes, Certus LKXT Ablation Probes, Certus LN Ablation Probes, Certus PR Ablation Probes and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Ablation, Microwave And Accessories | NEY | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Manufacturer | accessdata.fda.gov |
| Table And Attachments, Operating-Room | BWN | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 4, 2024 | K232227 | ABLATE-IQ | JAK | Substantially Equivalent | Neuwave Medical, Inc. | accessdata.fda.gov |
| November 16, 2023 | K231738 | NEUWAVE Microwave Ablation System and Accessories | NEY | Substantially Equivalent | Neuwave Medical, Inc. | accessdata.fda.gov |
| August 11, 2022 | K220472 | NEUWAVE Microwave Ablation System and Accessories | NEY | Substantially Equivalent | Neuwave Medical, Inc. | accessdata.fda.gov |
| November 13, 2020 | K200081 | NEUWAVE Microwave Ablation System and Accessories | NEY | Substantially Equivalent | Neuwave Medical, Inc. | accessdata.fda.gov |
| October 3, 2019 | K192427 | Ablation Confirmation | JAK | Substantially Equivalent | Neuwave Medical, Inc. | accessdata.fda.gov |
| March 9, 2017 | K163118 | FLEX Microwave Ablation System and Accessories | NEY | Substantially Equivalent | Neuwave Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Ablation, Microwave And Accessories
- All makers of System, X-Ray, Tomography, Computed
- All makers of Table And Attachments, Operating-Room
Updated April 4, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.