510(k) Report

Devices descending from K061746

12 later devices reach Collaguard, Model Fcia,Fcib,Fcic,and Fcid through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092805Collagen SpongeInnocoll Pharmaceuticals201010—
+1K081782CollievaInnocoll Pharmaceuticals200811—
+2K120339ProcollInnocoll Pharmaceuticals20120—
+2K103648Collagen PowderInnocoll Pharmaceuticals, Ltd.20110—
+2K110388Collacare DentalInnocoll Pharmaceuticals, Ltd.20116—
+2K100574CollexaInnocoll Pharmaceuticals20100—
+3K133290Collacare DentalInnocoll Pharmaceuticals20141—
+3K122115Collagen Dental Wound DressingsCollagen Matrix, Inc.20125—
+4K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)20250—
+4K152600Collagen Dental Wound DressingsCollagen Matrix, Inc.201621
+5K243071Bovine Dermis Collagen Dermal MatrixCollagen Matrix, Inc.20240—
+5K230529HealiAid Dental Collagen Wound DressingMaxigen Biotech, Inc.20230—