FDA 510(k)

DERMABOND PRINEO Skin Closure System

K-Number: K163645 · 2017-04-21

Decision Date2017-04-21

Product CodeOMD

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DERMABOND PRINEO Skin Closure System is a medical device manufactured by Ethicon, LLC. It received FDA 510(k) clearance on 2017-04-21 under approval number K163645. 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 DERMABOND PRINEO Skin Closure System?

DERMABOND PRINEO Skin Closure System is a medical device that received FDA 510(k) clearance on 2017-04-21. It is manufactured by Ethicon, LLC. The 510(k) number is K163645.

When was DERMABOND PRINEO Skin Closure System approved by the FDA?

DERMABOND PRINEO Skin Closure System received FDA 510(k) clearance on 2017-04-21, under approval number K163645.

What company makes DERMABOND PRINEO Skin Closure System?

DERMABOND PRINEO Skin Closure System is manufactured by Ethicon, LLC.

What is the FDA product code for DERMABOND PRINEO Skin Closure System?

The FDA product code for DERMABOND PRINEO Skin Closure System 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 Ethicon, LLC

K153611Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device

Related Devices (Code: OMD)

K171442Exofin Fusion Skin Closure SystemChemence Medical, Inc. K191461Exofin Fusion Skin Closure SystemChemence Medical, Inc. K213512DERMABOND PRINEO Skin Closure SystemETHICON, Inc. K211878LiquiBand XLAdvanced Medical Solutions Limited K233460CM00622 LINC Skin Closure System (CM00622 LINC)Connexicon Medical , Ltd.

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.