510(k) Report

Devices descending from K081635

10 later devices reach Integra Meshed Bilayer Wound Matrix through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213498PELNAC Meshed Bilayer Wound MatrixGunze Limited20220—
+1K210135PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing3M Healthcare Business Group20221—
+1K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+1K112568Aongen Dental Collagen MatrixAeon Astron Europe B.V.20120—
+1K102946Coreleader Colla-Pad Model CS 03030Coreleader Biotech Co., Ltd.20110—
+2K251999Promogran Prisma™ Collagen Matrix with ORC and SilverSolventum Germany GmbH20260—
+2K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+3K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+4K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+4K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—