DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX— 510(k) K120284

Clearance details

Applicant

Coloplast A/S

Product code

Code NEW

Device class

Class 2

Regulation

21 CFR 878.4840

Advisory panel

General, Plastic Surgery

Date received

2012-01-31

Decision date

2012-05-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Plymouth, MN, US

• K253879 — MONOFIX PDO2026-08-25
• K261988 — Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture2026-07-09
• K252171 — Barbed PDO Suture2026-06-12
• K252047 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices2026-05-18
• K243897 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture2025-11-12

• K262045 — Luja Soft2026-07-07
• K221874 — Altis Single Incision Sling System2023-02-15
• K220420 — Saffron Fixation System2022-06-10
• K191536 — Biatain Silicone Ag2020-02-21
• K181811 — ReTrace Ureteral Access Sheath2018-09-07

Death

32

Injury

2,179

Malfunction

8,975

Total

11,186

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1486-2013 — Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. 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 know-typing by holding the suture.Class II·Terminated·Coloplast Manufacturing US, LLC·20130513

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120284.