510(k) Report

Devices descending from K013056

21 later devices reach Gelclair Concentrated Oral Gel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101769EpisilCamurus AB20110—
+1K081372Gelx Oral GelBmg Pharma, LLC20091—
+1K082553Rexastom Oral EaseRexaderm, Inc.20080—
+1K053342Gengigel MouthrinseRicerfarma Srl20071—
+1K062795Mugard Mucoadhesive Oral Wound RinseAccess Pharmaceuticals, Inc.20065—
+1K043587Sucralfate and Carafate Paste KitsPatrick D. Mcgrath Ph.D20064—
+1K042400Mucotrol Concentrated Oral Gel WaferBelcher Pharmaceuticals, Inc.200401
+1K040950Aloclair Oral GelSinclair Pharmaceuticals, Ltd.20043—
+1K023155Aloclair Oral RinseSinclair Pharmaceuticals, Ltd.20025—
+2K203091MucoLock Oral GelPcca, Inc.20210—
+2K140558ProctigardAccess Pharmaceuticals, Inc.20144—
+2K130959Aftamed Mouthwash; Aftamed Gel; Aftamed Spray; Aftamed Shield; Aftamed Junior GelBioplax Limited20140—
+2K123904ProthelialMueller Medical International, LLC20132—
+2K082856Carapaste Oral Wound DressingMcgrath Pharmaceuticals, Inc.20083—
+2K042722Aloclair Oral SpraySinclair Pharmaceuticals, Ltd.20052—
+3K213552PuraStat-RM3-D Matrix, Inc.20223—
+3K202000Silatrix Oral GelSa3, LLC202011
+4K261504PuraStat-RM3-D Matrix, Inc.20260—
+4K252425Silatrix Oral GelSa3, LLC20250—
+4K242634PuraStat3-D Matrix Europe SAS20252—
+5K253923PuraStat3-D Matrix Europe SAS20261—