MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE— 510(k) K013274

Substantially Equivalent

Cp Medical

FDA 510(k) clearance K013274 for MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE, Substantially Equivalent on 2001-11-16. Applicant: Cp Medical.

Clearance details

Applicant: Cp Medical
Product code: Code NEW
Advisory panel: General, Plastic Surgery
Date received: 2001-10-01
Decision date: 2001-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, 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.