The following data is part of a premarket notification filed by Athena Surgical, Llc with the FDA for Athena Surgical Rmus System.
| Device ID | K210087 |
| 510k Number | K210087 |
| Device Name: | Athena Surgical RMUS System |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | Athena Surgical, LLC 6110 Blue Circle Drive, Suite 280 Minnetonka, MN 55343 |
| Contact | Greg Slusser |
| Correspondent | Kellen Hills Medavise Consulting 8725 Columbine Rd. #44952 Eden Prairie, MN 55344 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-13 |
| Decision Date | 2021-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003619827 | K210087 | 000 |
| 20860003619814 | K210087 | 000 |
| 00860003619803 | K210087 | 000 |