Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CM00622 LINC Skin Closure System (CM00622 LINC)

K-Number: K233460 · 2024-07-15

ApplicantConnexicon Medical , Ltd.
Decision Date2024-07-15
Product CodeOMD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CM00622 LINC Skin Closure System (CM00622 LINC) is a medical device manufactured by Connexicon Medical , Ltd.. It received FDA 510(k) clearance on 2024-07-15 under approval number K233460. The device is classified under product code OMD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CM00622 LINC Skin Closure System (CM00622 LINC)?

CM00622 LINC Skin Closure System (CM00622 LINC) is a medical device that received FDA 510(k) clearance on 2024-07-15. It is manufactured by Connexicon Medical , Ltd.. The 510(k) number is K233460.

When was CM00622 LINC Skin Closure System (CM00622 LINC) approved by the FDA?

CM00622 LINC Skin Closure System (CM00622 LINC) received FDA 510(k) clearance on 2024-07-15, under approval number K233460.

What company makes CM00622 LINC Skin Closure System (CM00622 LINC)?

CM00622 LINC Skin Closure System (CM00622 LINC) is manufactured by Connexicon Medical , Ltd..

What is the FDA product code for CM00622 LINC Skin Closure System (CM00622 LINC)?

The FDA product code for CM00622 LINC Skin Closure System (CM00622 LINC) is OMD.

Related Clinical Trials

NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT05887700 Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up RECRUITING NCT07581977 A Novel Two-Tooth Clip for ESD and EFTR of GIST RECRUITING NCT06686485 cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia RECRUITING NCT07349121 OPTION-EMEA Clinical Trial NOT_YET_RECRUITING NCT06293430 Registry on Luma Vision's VERAFEYE System (ENLIgHT) NOT_YET_RECRUITING

Other Devices by Connexicon Medical , Ltd.

K233458CM005 Standard (CM005); CM004 Mini (CM004)

Related Devices (Code: OMD)

K171442Exofin Fusion Skin Closure SystemChemence Medical, Inc. K163645DERMABOND PRINEO Skin Closure SystemEthicon, LLC K191461Exofin Fusion Skin Closure SystemChemence Medical, Inc. K213512DERMABOND PRINEO Skin Closure SystemETHICON, Inc. K211878LiquiBand XLAdvanced Medical Solutions Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑