510(k) Report

Devices descending from K012113

26 later devices reach Indwelling Fecal Management System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112342Flexi-Seal Signal Fecal Management SystemConvatec, Inc.20128—
+1K083153Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007Hollister, Inc.20097—
+1K032734Convatec Fecal Management SystemConvatec, A Bristol-Myers Squibb Co.2004143
+1K023344Indwelling Fecal Management System-Non-SterileBowel Management Systems, LLC200216—
+2K150350Flexi-Seal Signal Fecal Management SystemConvatec, Ltd.20156—
+2K133251Bard Dignishield Stool Management SystemC.R. Bard, Inc.20140—
+2K133881Macy CatheterHospi Corporation20140—
+2K102391Bard Dignishield Stool Management SystemC.R. Bard, Inc.20104—
+2K100273Instaflo Bowel Catheter System KitHollister, Inc.20102—
+2K083770Coloplast Peristeen Anal Irrigation (Pai) SystemColoplast A/S20095—
+2K073598Bard Dignicare Stool Management SystemC.R. Bard, Inc.20085—
+3K221400hygh-tec drainageCreative Balloons GmbH20231—
+3K193325Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement…Prosys International, Ltd.20200—
+3K162906Flexi-Seal PROTECT Fecal Management SystemConvatec20172—
+3K133465Consure Stool Management SystemConsure Medical Pvt, Ltd.20142—
+3K123804Instaflo Bowel Catheter System KitHollister, Inc.20131—
+3K112860Peristeen Anal Irrigation System, Peristeen Anal Irrigation Accessory Unit, Peristeen…Coloplast A/S20123—
+3K103254Peristeen Anal Irrigation System, Irrigation Accessory Unit, Irrigation Rectal Catheter…Coloplast A/S20114—
+4K242336hygh-tec Drainage IIAmb Medtec20250—
+4K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)Convatec Limited20191—
+4K153506Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool…Consure Medical Pvt, Ltd.20161—
+4K140310Peristeen Anal Irrigation SystemColoplast A/S20152—
+5K243228Flexi-Seal AIR (with ENFit Connector)Convatec20250—
+5K212444Qora Stool Management KitCm Technologies, Inc.20210—
+5K190977Navina Smart System, Navina Classic SystemDentsply Sirona20190—
+5K170487Navina Classic SystemDentsply Sirona20171—