510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233460Substantially Equivalent

CM00622 LINC Skin Closure System (CM00622 LINC)

Connexicon Medical, Ltd., Dublin, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233460 is the FDA 510(k) clearance record for CM00622 LINC Skin Closure System (CM00622 LINC), a class II device, cleared for Connexicon Medical , Ltd. on under FDA product code OMD (Cutaneous Tissue Adhesive With Mesh). FDA's definition for product code OMD reads: "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...". FDA records list 2 510(k) clearances for Connexicon Medical , Ltd. As of , FDA records show no recalls naming K233460.

Clearance record

Decision date
Received
(266 days to decision)
Product code
OMD Cutaneous Tissue Adhesive With Mesh
Regulation
21 CFR 878.4011
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Connexicon Medical , Ltd. Synergy Centre, Dublin, IE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OMD

Trailing 12 months

FDA records hold no clearances under product code OMD in the trailing twelve months.

FDA records show no clearances under product code OMD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OMD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260