510(k) Report

Devices descending from DEN090005

10 later devices reach Prineo Skin Closure System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171442Exofin Fusion Skin Closure SystemChemence Medical, Inc.20172—
+1K152490DERMABOND PRINEO Skin Closure SystemETHICON, Inc.20150—
+1K133864Dermabond Prineo Skin Closure SystemETHICON, Inc.201491
+2K234114CUTIVA (TM) Topical Skin Adhesive (RM-1700); CUTIVA (TM) PLUS Skin Closure System…Okapi Medical, LLC Dba Resivant Medical20241—
+2K233460CM00622 LINC Skin Closure System (CM00622 LINC)Connexicon Medical, Ltd.20240—
+2K213512DERMABOND PRINEO Skin Closure SystemETHICON, Inc.20210—
+2K191461Exofin Fusion Skin Closure SystemChemence Medical, Inc.20201—
+2K163645DERMABOND PRINEO Skin Closure SystemEthicon, LLC20170—
+3K250950CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)Okapi Medical, LLC Dba Resivant Medical20250—
+3K211878LiquiBand XLAdvanced Medical Solutions Limited20220—