K173527 is an FDA 510(k) clearance for the Digitex Delivery Device. This device is classified as a Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse (Class II - Special Controls, product code PWI).
Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on February 12, 2018, 90 days after receiving the submission on November 14, 2017.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4910. Used To Aid In Insertion, Placement, Fixation, Or Anchoring Of Surgical Mesh For Transvaginal Pelvic Organ Prolapse Repair.
| 510(k) Number | K173527 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2017 |
| Decision Date | February 12, 2018 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PWI — Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4910 |
| Definition | Used To Aid In Insertion, Placement, Fixation, Or Anchoring Of Surgical Mesh For Transvaginal Pelvic Organ Prolapse Repair |