# K120284: Digitex Suture Delivery System, Digitexpolypropylene Suture Cartridge Size 0, with Needle and Without Needle, Digitex

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast A/S
- Decided: May 23, 2012 after 113 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K900198 (1990). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093112: Digitex Suture Delivery System, Model 52025, Digitex Suture Cartridge (Size O), Model 52026, Digitex Suture Cartridge, Coloplast Manufacturing Us, LLC (2010) Summary page 1.
- K930738: Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc, Deknatel, Inc. (1994) Summary page 1.
- K030212: Monodek Synthetic Absorbable Surgical Suture, Genzyme Biosurgery (2003) Summary page 1.
- K991191: Bondek Polyglycolic Acid Synthetic Absorbable Surgical Suture, Genzyme Surgical Product (Genzyme Biosurgery) (1999) Summary page 1.
- K992088: Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture, Genzyme Surgical Product (Genzyme Biosurgery) (1999) Summary page 1.

## Recalls of this device
- May 13, 2013 · Class II · Z-1486-2013: Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2-0 because it is mislabeled with a three year expiration date.

## Indications for use
The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and knot-tying by holding the suture. The Digitex Suture Cartridge holds sterile suture indicated for soft tissue approximation.

Source page: https://510kreport.com/device/K120284
Methodology: https://510kreport.com/methodology