Surgical Gut Suture— 510(k) K142656

Substantially Equivalent

Covidien

FDA 510(k) clearance K142656 for Surgical Gut Suture, Substantially Equivalent on 2015-01-29. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code GAL
Advisory panel: General, Plastic Surgery
Date received: 2014-09-18
Decision date: 2015-01-29
Decision: Substantially Equivalent
Clearance type: Special
Location: North Haven, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAL

product code GAL

Malfunction: 681
Other: 1
Total: 682

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.