Data / Medical devices / United States / MedWaves, Inc
MedWaves, Inc: FDA-registered device maker in San Diego, CA, United States, 2 510(k) clearances
MedWaves, Inc is registered with the FDA (registration 3005382058) in San Diego, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 25, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005382058
- Address
- 16760 West Bernardo Drive, San Diego, CA, United States, 92127
- Owner or operator
- MedWaves (10028164)
- Roles
- Manufacturer
- First device listed
- April 6, 2016
- Registered through
- 2026
- Brand names listed
- AveCure Microwave Ablation System, Avecure Microwave Ablation System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Ablation, Microwave And Accessories | NEY | 2 | 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 |
|---|---|---|---|---|---|---|
| November 25, 2020 | K192406 | AveCure BT Microwave Ablation System | NEY | Substantially Equivalent | Medwaves, Inc. | accessdata.fda.gov |
| August 26, 2015 | K143203 | AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe | NEY | Substantially Equivalent | Medwaves Incorporated | accessdata.fda.gov |
Compare with other makers
Updated November 25, 2020. 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.