The following data is part of a premarket notification filed by Urocure Llc with the FDA for Arcto Transobturator Sling System.
| Device ID | K222468 |
| 510k Number | K222468 |
| Device Name: | ArcTO Transobturator Sling System |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | UroCure LLC 701 North 3rd Street, Suite 110 Minneapolis, MN 55401 |
| Contact | John Nealon |
| Correspondent | Denise Lenz Libra Medical Inc. 8401 73rd Avenue North, Suite 63 Brooklyn Park, MN 55428 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-16 |
| Decision Date | 2022-09-15 |