The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Digitex Delivery Device.
| Device ID | K173527 |
| 510k Number | K173527 |
| Device Name: | Digitex Delivery Device |
| Classification | Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse |
| Applicant | Coloplast A/S 1601 West River Road North Minneapolis, MN 55411 |
| Contact | Nikita Basandra |
| Correspondent | Nikita Basandra Coloplast A/S 1601 West River Road North Minneapolis, MN 55411 |
| Product Code | PWI |
| CFR Regulation Number | 884.4910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-14 |
| Decision Date | 2018-02-12 |
| Summary: | summary |