VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED— 510(k) K123034

Substantially Equivalent

Unilene Sac

FDA 510(k) clearance K123034 for VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED, Substantially Equivalent on 2013-05-28. Applicant: Unilene Sac.

Clearance details

Applicant: Unilene Sac
Product code: Code GAR
Advisory panel: General, Plastic Surgery
Date received: 2012-09-28
Decision date: 2013-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, US

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Adverse events under product code GAR

product code GAR

Injury: 422
Malfunction: 3,386
Other: 4
Total: 3,812

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.