UNICRYL M— 510(k) K042285

Clearance details

Applicant

United Medical Industries Co. , Ltd.

Product code

Product code NEW

Device class

Class 2

Regulation

21 CFR 878.4840

Advisory panel

General, Plastic Surgery

Date received

2004-08-24

Decision date

2004-12-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Riyadh, Central Province, SA

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• 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

• K072644 — UNICRYL QUICK2007-11-07
• K072645 — UNIGLACTIN2007-11-07
• K072646 — UNICAPRONE2007-11-07
• K042287 — UNIPLAIN & UNICHROM2005-09-07
• K042288 — UNICRYL2004-12-27

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 →