UNISILK— 510(k) K042282

Substantially Equivalent

United Medical Industries Co. , Ltd.

FDA 510(k) clearance K042282 for UNISILK, Substantially Equivalent on 2004-12-01. Applicant: United Medical Industries Co. , Ltd..

Clearance details

Applicant: United Medical Industries Co. , Ltd.
Product code: Code GAP
Advisory panel: General, Plastic Surgery
Date received: 2004-08-24
Decision date: 2004-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Riyadh, Central Province, SA

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Adverse events under product code GAP

product code GAP

Death: 3
Injury: 491
Malfunction: 2,253
Total: 2,747

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.