510(k) Report

Devices descending from K001148

18 later devices reach Merogel Otologic Pack through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150594Biodesign Otologic Repair GraftCook Biotech Incorprated20152—
+1K070886Merogel Injectable Bioresorbable StentMedtronic, Inc.20071—
+1K043035Sepragel Ent Bioresorbable Packing/StentGenzyme Corporation200510—
+1K040501DBX Demineralized Bone Matrix Putty, Paste and MixMusculoskeletal Transplant Foundation20053—
+2K161000Biodesign Otologic Repair GraftCook Biotech Incorporated20161—
+2K122434Merogel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic GelMedtronic Xomed20120—
+2K113585Nasal/Epistaxis PackCogent Therapeutics, LLC20127—
+2K080462Progenix DBM PuttyMedtronic Sofamor Danek20082—
+3K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly…Cook Biotech Incorporated202401
+3K141704Novashield Injectable Nasal Packing and StentMedtronic, Inc.20142—
+3K140992Arthrocare Nasastent CMC Nasal DressingArthroCare Corporation20140—
+3K122494Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC20132—
+3K082463ProgenixMedtronic Sofamor Danek20080—
+3K081950Progenix PlusMedtronic Sofamor Danek, Inc.20081—
+4K181696ChitoZolveGyrus Acmi, Inc.20180—
+4K172179Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd.20171—
+4K141816HemoporePolyganics B.V.,20140—
+5K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.20230—