K041048

Substantially Equivalent

POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE

Applicant: Internacional Farmaceutica, S.A. DE C.V.
Product code: NEW
Advisory panel: General, Plastic Surgery
Date received: 2004-04-22
Decision date: 2004-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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.