VITAL SUTURES, SUTUREX, CIRUGIA PERUANA— 510(k) K100780

Substantially Equivalent

Unilene Sac

FDA 510(k) clearance K100780 for VITAL SUTURES, SUTUREX, CIRUGIA PERUANA, Substantially Equivalent on 2010-12-14. Applicant: Unilene Sac.

Clearance details

Applicant: Unilene Sac
Product code: Code NEW
Advisory panel: General, Plastic Surgery
Date received: 2010-03-19
Decision date: 2010-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwood Village, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NEW

product code NEW

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 →

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