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

Product 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

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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.