EXB · Collector, Ostomy

Gastroenterology, Urology · 21 CFR 876.5900 · Class 1

Overview

Showing 20 most recent of 102 cleared devices.

Record	Device Name	Applicant	Decision Date	Decision
K252140	Heylo System	Coloplast Corp.	Oct 6, 2025	SESE
K181643	SmartBag (SmartPouch)	11 Health Technologies Limited	Nov 16, 2018	SESE
K140938	OSTOM-I ALERT	11 Health and Technologies, LLC	Oct 10, 2014	SESE
K922730	LAKE OSTOMY CARE SET	Lake Medical Products, Inc.	Dec 30, 1993	SESK
K882878	ODOR-END EMERGENCY CLEAN UP POWDER	Cdc Products Corp.	Dec 8, 1988	SESE
K881636	CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)	Coloplast A/S	Jul 13, 1988	SESE
K880306	EMERGENCY-CLEAN UP(TM) ECP	Cdc Products Corp.	May 20, 1988	SESE
K872294	COMBINATION NITE DRAINAGE UNIT	Arnold Technologies	Dec 29, 1987	SESE
K873929	'CATCH-IT' OR FECAL CONTAINMENT DEVICE	Midwest Medical Co.	Dec 3, 1987	SESE
K871526	ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER	Cox Family Laboratories, Inc.	Oct 13, 1987	SESE
K871738	OSTO-PURE	Clearchem Corp.	Aug 12, 1987	SESE
K871628	PALEX (R) OSTOMY	Industrias Palex C/O Dma Med-Chem Corp.	Jul 8, 1987	SESE
K870577	E-Z LOOP	John F. Greer Co., Inc.	Apr 17, 1987	SESE
K870531	EZ TAC FILTER	John F. Greer Co., Inc.	Apr 10, 1987	SESE
K870136	PERSONAL PUNCH	Arnold Technologies	Apr 1, 1987	SESE
K864189	ULTRA-GEL - #4083	John F. Greer Co., Inc.	Dec 4, 1986	SESE
K862631	BARD IRYFIX(TM) STOMA CAP	C.R. Bard, Inc.	Oct 16, 1986	SESE
K861070	COLOPLAST CONVEX RING	Coloplast A/S	Jun 16, 1986	SESE
K855019	DURAHESIVE PROTECTIVE BARRIER WIPE	Convatec, A Division of E.R. Squibb & Sons	Apr 16, 1986	SESE
K854726	MEDI-WIPES UNITED ANTISEPTIC SKIN PREP	Pfizer, Inc.	Feb 24, 1986	SESE