510(k) Report

Devices descending from K043035

10 later devices reach Sepragel Ent Bioresorbable Packing/Stent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113585Nasal/Epistaxis PackCogent Therapeutics, LLC20127—
+1K070886Merogel Injectable Bioresorbable StentMedtronic, Inc.20071—
+2K141704Novashield Injectable Nasal Packing and StentMedtronic, Inc.20142—
+2K140992Arthrocare Nasastent CMC Nasal DressingArthroCare Corporation20140—
+2K122494Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC20132—
+2K122434Merogel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic GelMedtronic Xomed20120—
+3K181696ChitoZolveGyrus Acmi, Inc.20180—
+3K172179Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd.20171—
+3K141816HemoporePolyganics B.V.,20140—
+4K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.20230—