510(k) Report

Devices descending from K023344

16 later devices reach Indwelling Fecal Management System-Non-Sterile through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133881Macy CatheterHospi Corporation20140—
+1K083770Coloplast Peristeen Anal Irrigation (Pai) SystemColoplast A/S20095—
+1K083153Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007Hollister, Inc.20097—
+1K073598Bard Dignicare Stool Management SystemC.R. Bard, Inc.20085—
+2K133251Bard Dignishield Stool Management SystemC.R. Bard, Inc.20140—
+2K112860Peristeen Anal Irrigation System, Peristeen Anal Irrigation Accessory Unit, Peristeen…Coloplast A/S20123—
+2K103254Peristeen Anal Irrigation System, Irrigation Accessory Unit, Irrigation Rectal Catheter…Coloplast A/S20114—
+2K102391Bard Dignishield Stool Management SystemC.R. Bard, Inc.20104—
+2K100273Instaflo Bowel Catheter System KitHollister, Inc.20102—
+3K140310Peristeen Anal Irrigation SystemColoplast A/S20152—
+3K133465Consure Stool Management SystemConsure Medical Pvt, Ltd.20142—
+3K123804Instaflo Bowel Catheter System KitHollister, Inc.20131—
+4K190977Navina Smart System, Navina Classic SystemDentsply Sirona20190—
+4K170487Navina Classic SystemDentsply Sirona20171—
+4K153506Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool…Consure Medical Pvt, Ltd.20161—
+5K212444Qora Stool Management KitCm Technologies, Inc.20210—