The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Artisyn Y-shaped Mesh.
| Device ID | K113205 |
| 510k Number | K113205 |
| Device Name: | ARTISYN Y-SHAPED MESH |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| Applicant | ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | Sarah Mcmanus |
| Correspondent | Sarah Mcmanus ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Product Code | OTO |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-31 |
| Decision Date | 2012-06-11 |
| Summary: | summary |