The following data is part of a premarket notification filed by Urocure Llc with the FDA for Arctv Transvaginal Sling System.
| Device ID | K183134 |
| 510k Number | K183134 |
| Device Name: | ArcTV Transvaginal Sling System |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | UroCure LLC 4701 North 3rd Street, Suite 110 Minneapolis, MN 55401 |
| Contact | John Nealon |
| Correspondent | Ming Cheng Chew Libra Medical Inc 8401 73rd Ave N, Suite 63 Brooklyn Park, MN 55428 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-13 |
| Decision Date | 2019-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860368002401 | K183134 | 000 |