Cleared Traditional

K233460 - CM00622 LINC Skin Closure System (CM00622 LINC) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233460 · Connexicon Medical , Ltd. · General & Plastic Surgery device
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Jul 2024
Decision
266d
Days
Class 2
Risk

K233460 is an FDA 510(k) clearance for the CM00622 LINC Skin Closure System (CM00622 LINC). Classified as Cutaneous Tissue Adhesive With Mesh (product code OMD), Class II - Special Controls.

Submitted by Connexicon Medical , Ltd. (Dublin, IE). The FDA issued a Cleared decision on July 15, 2024 after a review of 266 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4011 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Connexicon Medical , Ltd. devices

Submission Details

510(k) Number K233460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2023
Decision Date July 15, 2024
Days to Decision 266 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 114d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OMD Cutaneous Tissue Adhesive With Mesh
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4011
Definition For Topical Application Only To Hold Closed Easily Approximated Skin Edges Of Wounds Such As Wounds From Surgical Incisions, Including Punctures From Minimally Invasive Surgery, And Simple Thorough Cleansed, Trauma-induced Lacerations. The Device May Be Used In Conjunction With, But Not In Place Of, Deep Dermal Sutures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.