Data / Medical devices / United States / Athena Surgical
Athena Surgical: FDA-registered device maker in Minnetonka, MN, United States, 1 510(k) clearance
Athena Surgical is registered with the FDA (registration 3018783201) in Minnetonka, MN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 12, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018783201
- Address
- 6110 Blue Circle Drive Suite 280, Minnetonka, MN, United States, 55343
- Owner or operator
- Athena Surgical (10081489)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- April 19, 2021
- Registered through
- 2026
- Brand names listed
- Athena Surgical RMUS System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | OTN | 2 | Complaint file establishment, Specification developer | 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 12, 2021 | K210087 | Athena Surgical RMUS System | OTN | Substantially Equivalent | Athena Surgical, LLC | accessdata.fda.gov |
Compare with other makers
Updated April 12, 2021. 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.