FDA 510(k)

Exofin Fusion Skin Closure System

K-Number: K191461 · 2020-06-05

Decision Date2020-06-05

Product CodeOMD

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Exofin Fusion Skin Closure System is a medical device manufactured by Chemence Medical, Inc.. It received FDA 510(k) clearance on 2020-06-05 under approval number K191461. 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 Exofin Fusion Skin Closure System?

Exofin Fusion Skin Closure System is a medical device that received FDA 510(k) clearance on 2020-06-05. It is manufactured by Chemence Medical, Inc.. The 510(k) number is K191461.

When was Exofin Fusion Skin Closure System approved by the FDA?

Exofin Fusion Skin Closure System received FDA 510(k) clearance on 2020-06-05, under approval number K191461.

What company makes Exofin Fusion Skin Closure System?

Exofin Fusion Skin Closure System is manufactured by Chemence Medical, Inc..

What is the FDA product code for Exofin Fusion Skin Closure System?

The FDA product code for Exofin Fusion Skin Closure System is OMD.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING 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 NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Other Devices by Chemence Medical, Inc.

K162352derma+flex QS High Viscosity Tissue Adhesive K171442Exofin Fusion Skin Closure System K200264Exofin High Viscosity Topical Skin Adhesive K212246Exofin Precision Pen

Related Devices (Code: OMD)

K171442Exofin Fusion Skin Closure SystemChemence Medical, Inc. K163645DERMABOND PRINEO Skin Closure SystemEthicon, LLC K213512DERMABOND PRINEO Skin Closure SystemETHICON, Inc. K211878LiquiBand XLAdvanced Medical Solutions Limited K233460CM00622 LINC Skin Closure System (CM00622 LINC)Connexicon Medical , Ltd.

Official Source

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