CM005 Standard (CM005); CM004 Mini (CM004)— 510(k) K233458

Name: FDA 510(k) clearance K233458
Creator: U.S. Food and Drug Administration
Published: 2024-07-15

Substantially Equivalent

Connexicon Medical , Ltd.

FDA 510(k) clearance K233458 for CM005 Standard (CM005); CM004 Mini (CM004), Substantially Equivalent on 2024-07-15. Applicant: Connexicon Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Connexicon Medical , Ltd.
Product code: Code MPN
Device class: Class 2
Regulation: 21 CFR 878.4010
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 ↗

Recent devices under product code MPN

view all

More clearances from Connexicon Medical , Ltd.

view all

K233460 — CM00622 LINC Skin Closure System (CM00622 LINC)2024-07-15

Adverse events under product code MPN

product code MPN

Injury: 856
Other: 1
Total: 857

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.