CM00622 LINC Skin Closure System (CM00622 LINC)— 510(k) K233460

Substantially Equivalent

Connexicon Medical , Ltd.

FDA 510(k) clearance K233460 for CM00622 LINC Skin Closure System (CM00622 LINC), Substantially Equivalent on 2024-07-15. Applicant: Connexicon Medical , Ltd..

Clearance details

Applicant: Connexicon Medical , Ltd.
Product code: Code OMD
Advisory panel: General, Plastic Surgery
Date received: 2023-10-23
Decision date: 2024-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code OMD

product code OMD

Injury: 1,134
Total: 1,134

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.