# K173527: Digitex Delivery Device

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast A/S
- Decided: Feb 12, 2018 after 90 days
- Product code: PWI (Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse)
- Device class: 2
- Regulation: 21 CFR 884.4910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K931386 (1993). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172060: Capio SLIM Suture Capturing Device, Boston Scientific Corporation (2017) Summary page 4.

## Indications for use
The Digitex Delivery Device is a single-use device intended for use as an aid in suturing during transvaginal pelvic organ prolapse procedures with surgical mesh.

Source page: https://510kreport.com/device/K173527
Methodology: https://510kreport.com/methodology