The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Upsylon Y Mesh.
| Device ID | K122794 |
| 510k Number | K122794 |
| Device Name: | UPSYLON Y MESH |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| Applicant | BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Lauren Anderson |
| Correspondent | Lauren Anderson BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Product Code | OTO |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-12 |
| Decision Date | 2012-12-18 |
| Summary: | summary |