Product Code: EXB FDA class 1 21 CFR 876.5900

Collector, Ostomy

Gastroenterology, Urology

The ostomy collector is a pouching or collecting system worn over a surgically created stoma to collect intestinal or urinary output following procedures such as colostomy, ileostomy, or urostomy. It is classified as FDA Class 1, indicating minimal risk, subject only to general controls. The product code is EXB, regulated under 21 CFR 876.5900 in the Gastroenterology, Urology specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.

View on FDA

510(k)s

102

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: EXB
Device Class: FDA class 1
Regulation Number: 876.5900
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 102 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252140	Heylo System	Oct 06, 2025	Substantially Equivalent	Coloplast Corp.
K181643	SmartBag (SmartPouch)	Nov 16, 2018	Substantially Equivalent	11 Health Technologies Limited
K140938	OSTOM-I ALERT	Oct 10, 2014	Substantially Equivalent	11 Health and Technologies, LLC
K922730	LAKE OSTOMY CARE SET	Dec 30, 1993	Unknown	Lake Medical Products, Inc.
K882878	ODOR-END EMERGENCY CLEAN UP POWDER	Dec 08, 1988	Substantially Equivalent	Cdc Products Corp.
K881636	CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)	Jul 13, 1988	Substantially Equivalent	Coloplast A/S
K880306	EMERGENCY-CLEAN UP(TM) ECP	May 20, 1988	Substantially Equivalent	Cdc Products Corp.
K872294	COMBINATION NITE DRAINAGE UNIT	Dec 29, 1987	Substantially Equivalent	Arnold Technologies
K873929	'CATCH-IT' OR FECAL CONTAINMENT DEVICE	Dec 03, 1987	Substantially Equivalent	Midwest Medical Co.
K871526	ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER	Oct 13, 1987	Substantially Equivalent	Cox Family Laboratories, Inc.
K871738	OSTO-PURE	Aug 12, 1987	Substantially Equivalent	Clearchem Corp.
K871628	PALEX (R) OSTOMY	Jul 08, 1987	Substantially Equivalent	Industrias Palex C/O Dma Med-Chem Corp.
K870577	E-Z LOOP	Apr 17, 1987	Substantially Equivalent	John F. Greer Co., Inc.
K870531	EZ TAC FILTER	Apr 10, 1987	Substantially Equivalent	John F. Greer Co., Inc.
K870136	PERSONAL PUNCH	Apr 01, 1987	Substantially Equivalent	Arnold Technologies
K864189	ULTRA-GEL - #4083	Dec 04, 1986	Substantially Equivalent	John F. Greer Co., Inc.
K862631	BARD IRYFIX(TM) STOMA CAP	Oct 16, 1986	Substantially Equivalent	C.R. Bard, Inc.
K861070	COLOPLAST CONVEX RING	Jun 16, 1986	Substantially Equivalent	Coloplast A/S
K855019	DURAHESIVE PROTECTIVE BARRIER WIPE	Apr 16, 1986	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K854726	MEDI-WIPES UNITED ANTISEPTIC SKIN PREP	Feb 24, 1986	Substantially Equivalent	Pfizer, Inc.
K855018	DURAHESIVE WAFER WITH FLANGE	Feb 04, 1986	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K852471	CONFIDENT ODOR ELIMINATOR	Jan 14, 1986	Substantially Equivalent	Hallmark Industries, Inc.
K851680	OSTOMY BAGS ILEOSTOMY	Jun 27, 1985	Substantially Equivalent	Dbt Medical , Ltd.
K851679	OSTOMY BAGS COLOSTOMY	Jun 27, 1985	Substantially Equivalent	Dbt Medical , Ltd.
K851678	OSTOMY BAGS URETHEROSTOMY	Jun 27, 1985	Substantially Equivalent	Dbt Medical , Ltd.
K851840	STOMAHESIVE SKIN BARRIER STERILE	Jun 24, 1985	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K852297	JOHNSON & JOHNSON OSTOMY SIZE SELECTOR & BELT	Jun 12, 1985	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K851398	BARD PERISTOMAL PASTE	May 23, 1985	Substantially Equivalent	C.R. Bard, Inc.
K850751	DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY	May 23, 1985	Substantially Equivalent	Biolog, Inc.
K850750	DISPOSABLE UROSTOMY POUCH	May 23, 1985	Substantially Equivalent	Biolog, Inc.
K844938	UNITED SKIN BARRIERS	Jan 18, 1985	Substantially Equivalent	Pfizer, Inc.
K844685	COLOPLAST URO 2002 UROSTOMY SYSTEM	Jan 08, 1985	Substantially Equivalent	Coloplast A/S
K844406	JOHNSON & JOHN SON OSTOMY PASTE PROTECTIVWE SKIN	Nov 29, 1984	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K844046	UNITED SKIN BARRIERS	Nov 29, 1984	Substantially Equivalent	Howmedica Corp.
K842398	SUR-FIT IRRIGATION ADAPTER FACEPLATE	Oct 01, 1984	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K842119	OSTOMY OR UROSTOMY ABDOMINAL BELT OS	Sep 10, 1984	Substantially Equivalent	Atlas Surgical Belt Co., Inc.
K841173	OSTOMY FREEDOM KIT	Jul 09, 1984	Substantially Equivalent	Ellenberg Assoc.
K840723	SWEEN-A-PEEL PERISTOMAL WAFERS	May 07, 1984	Substantially Equivalent	Sween Corp.
K840568	ACTIVE LIFE ONE-PIECE CLOSED-END POUCH	May 02, 1984	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K840567	ACTIVE LIFE ONE-PIECE STOMA CAP	May 02, 1984	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K833567	COMFEEL PROTECTIVE FILM	May 02, 1984	Substantially Equivalent	Coloplast A/S
K841029	BANGORT LIFESTYLE COLOSTOMY POUCHES	Apr 04, 1984	Substantially Equivalent	Howmedica Corp.
K840269	MC 2000 OSTOMY POUCHES	Apr 02, 1984	Substantially Equivalent	Coloplast A/S
K840267	FILTRODER FILTERS	Apr 02, 1984	Substantially Equivalent	Coloplast A/S
K840265	MC 2002 OSTOMY POUCHES & SKIN FLANGES	Apr 02, 1984	Substantially Equivalent	Coloplast A/S
K840166	SUR-FIT UROSTOMY POUCH W/ACCUSEAL	Feb 04, 1984	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K834575	BARD KARAYA GUM WASHERS	Feb 04, 1984	Substantially Equivalent	C.R. Bard, Inc.
K833571	STERILE DRAINAGE SYSTEM	Jan 30, 1984	Substantially Equivalent	Coloplast A/S
K833565	COMFEEL PASTE	Jan 30, 1984	Substantially Equivalent	Coloplast A/S
K833569	COMFEEL BARRIER CREAM	Dec 27, 1983	Substantially Equivalent	Coloplast A/S
K833566	COMFEEL CLEANSER	Dec 27, 1983	Substantially Equivalent	Coloplast A/S
K833625	ACTIVE LIFE	Nov 28, 1983	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K830841	COLOSTOMY BAG	Jul 19, 1983	Substantially Equivalent	C & D Colostomy Pad Corp.
K830945	SUR-FIT FLEXIBLE	Apr 12, 1983	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K821271	BARD PROTECTIVE BARRIER FILM	Jul 02, 1982	Substantially Equivalent	C.R. Bard, Inc.
K821680	HOLLISTER CATHETER ACCESS. PORT	Jun 24, 1982	Substantially Equivalent	Hollister, Inc.
K820493	DEEP CONVEX FACE PLATE	Mar 10, 1982	Substantially Equivalent	Smith'S Ostomy Products, Inc.
K820167	LAMINATED KARAYA GUM WASHERS	Feb 18, 1982	Substantially Equivalent	Atlantic Surgical
K813270	FECAL INCONTINENCE COLLATOR	Dec 14, 1981	Substantially Equivalent	Hollister, Inc.
K813269	TWO PIECE OSTOMY SYSTEM	Dec 03, 1981	Substantially Equivalent	Hollister, Inc.
K813080	WOUND DRAINAGE MANAGEMENT SYSTEMS	Nov 17, 1981	Substantially Equivalent	Howmedica Corp.
K812582	CANCEL	Sep 23, 1981	Substantially Equivalent	Bio Systems, Inc.
K811240	SUR-FIT LOOP OSTOMY O.R. SET	Jun 16, 1981	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K811300	ECONOMY OPEN END DRAINAGE BAG	Jun 09, 1981	Substantially Equivalent	Economy Plus
K811239	SUR-FIT DISPOSABLE CONVEX INSERT	Jun 09, 1981	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K810726	FORMULATION CHANGE IN UNITED SKIN BARR	Jun 02, 1981	Substantially Equivalent	Howmedica Corp.
K811163	SUR-FIT DISPOSABLE FANGE CAP	May 21, 1981	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K810812	DRAINING-WOUND MGMT. SYSTEM	Apr 17, 1981	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K810807	HOLLISEAL OSTOMY SKIN BARRIER	Apr 07, 1981	Substantially Equivalent	Hollister, Inc.
K810710	HOLLISTER SKIN BARRIER B	Apr 07, 1981	Substantially Equivalent	Hollister, Inc.
K810709	HOLLISTER SKIN BARRIER A	Apr 07, 1981	Substantially Equivalent	Hollister, Inc.
K803082	ADHESIVE PERISTOMAL COVERING W/WO CONN.	Dec 22, 1980	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K803048	VANCE UROSTOMY APPLIANCE	Dec 22, 1980	Substantially Equivalent	Vance Products, Inc.
K802677	CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON	Nov 12, 1980	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K802424	OSTOMATE THIRD HAND	Oct 31, 1980	Substantially Equivalent	Smith'S Ostomy Products, Inc.
K801703	SUR-FIT SYSTEM STERILE O.R. SETS	Sep 09, 1980	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K801702	SUR-FIT SYSTEM PRE-OPERATION SET	Aug 27, 1980	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K801503	HOLLISTER KARAYA SEAL RING	Aug 13, 1980	Substantially Equivalent	Hollister, Inc.
K801471	SUPER BANISH DEODORANT	Jul 28, 1980	Substantially Equivalent	Howmedica Corp.
K800750	STOMAHESIVE STERILE WAFER	May 08, 1980	Substantially Equivalent	Squibb & Sons, Inc.
K800495	SUR-FIT UROSTOMY POUCH & URINARY BAG	Apr 08, 1980	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K792382	STOMAHESIVE POWDER	Dec 20, 1979	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K792381	BONGORT ODOR BARRIER DRAIN	Dec 10, 1979	Substantially Equivalent	Howmedica Corp.
K792139	FEATHER-LITE URINARY DIV. POUCH	Nov 13, 1979	Substantially Equivalent	Howmedica Corp.
K791535	HOLLISTER STOMA POUCH WITH MICRO ADHES	Oct 26, 1979	Substantially Equivalent	Hollister, Inc.
K791526	HOLLISTER STOMA POUCH SKIN BARRIER	Oct 26, 1979	Substantially Equivalent	Hollister, Inc.
K791525	HOLLISTER KARAYA PASTE	Oct 26, 1979	Substantially Equivalent	Hollister, Inc.
K791534	HOLLISTER UROSTOMY POUCH	Oct 09, 1979	Substantially Equivalent	Hollister, Inc.
K791581	COLOPLAST CARBON GAS FILTER	Oct 02, 1979	Substantially Equivalent	C.R. Bard, Inc.
K781373	OSTOMY APPLIANCE W/DEODORIZING FILTER	Sep 20, 1978	Substantially Equivalent	Hollister, Inc.
K781088	OSTOMY APPLIANCE BELT	Aug 18, 1978	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K781011	K-Z CONCENTRATE	Aug 17, 1978	Substantially Equivalent	K-Zyme Labs, Inc.
K780473	ILEX STOMA SEAL AND PROTECTIVE CREAM	May 16, 1978	Substantially Equivalent	Virgil Pichierri
K780511	SNAP-FIT	Apr 21, 1978	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K780454	ACTIVE-LIFE	Apr 21, 1978	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K771775	COLORPLAST TRANSVERSE SYSTEM	Sep 30, 1977	Substantially Equivalent	C.R. Bard, Inc.
K770439	STOMA BAG W/SKIN BARRIER SEAL RING	Apr 15, 1977	Substantially Equivalent	Hollister, Inc.
K770178	STOMA BAGS W/MICROPOROUS ADHESIVE	Feb 01, 1977	Substantially Equivalent	Hollister, Inc.
K760886	RECTAL TUBE DEVICE	Dec 09, 1976	Substantially Equivalent	Van Sickle Plastics Co.
K760878	BONGORT ILEOSTOMY POUCH	Dec 02, 1976	Substantially Equivalent	Howmedica Corp.
K760860	SILASTIC ILEAL RESERVOIR CATHETER	Nov 23, 1976	Substantially Equivalent	Dow Corning Corp. Healthcare Industries Materials
K760735	BONGORT SPECIAL ODORPROOF DRAIN	Oct 15, 1976	Substantially Equivalent	Howmedica Corp.