Sofsilk Coated Braided Silk Suture— 510(k) K241486

Substantially Equivalent

Covidien

FDA 510(k) clearance K241486 for Sofsilk Coated Braided Silk Suture, Substantially Equivalent on 2024-12-03. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code GAP
Advisory panel: General, Plastic Surgery
Date received: 2024-05-24
Decision date: 2024-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Haven, CT, US

Download summary PDF View on FDA.gov ↗

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.