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Collector, Ostomy

FDA product code EXB · 101 cleared devices

Class 1 Gastroenterology, Urology

Regulation: 21 CFR 876.5900
Review panel: GU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-10-15 – 2025-10-06

EXB 2025-10-06

Heylo™ System

Applicant Coloplast Corp.

K number K252140

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EXB 2018-11-16

SmartBag (SmartPouch)

Applicant 11 Health Technologies Limited

K number K181643

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EXB 1993-12-30

LAKE OSTOMY CARE SET

Applicant Lake Medical Products, Inc.

K number K922730

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EXB 1988-12-08

ODOR-END EMERGENCY CLEAN UP POWDER

Applicant Cdc Products Corp.

K number K882878

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EXB 1988-07-13

CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)

Applicant Coloplast A/S

K number K881636

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EXB 1988-05-20

EMERGENCY-CLEAN UP(TM) ECP

Applicant Cdc Products Corp.

K number K880306

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EXB 1987-12-29

COMBINATION NITE DRAINAGE UNIT

Applicant Arnold Technologies

K number K872294

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EXB 1987-12-03

'CATCH-IT' OR FECAL CONTAINMENT DEVICE

Applicant Midwest Medical Co.

K number K873929

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EXB 1987-10-13

ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER

Applicant Cox Family Laboratories, Inc.

K number K871526

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EXB 1987-08-12

OSTO-PURE

Applicant Clearchem Corp.

K number K871738

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EXB 1987-07-08

PALEX (R) OSTOMY

Applicant Industrias Palex C/O Dma Med-Chem Corp.

K number K871628

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EXB 1987-04-17

E-Z LOOP

Applicant John F. Greer Co., Inc.

K number K870577

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EXB 1987-04-10

EZ TAC FILTER

Applicant John F. Greer Co., Inc.

K number K870531

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EXB 1987-04-01

PERSONAL PUNCH

Applicant Arnold Technologies

K number K870136

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EXB 1986-12-04

ULTRA-GEL - #4083

Applicant John F. Greer Co., Inc.

K number K864189

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EXB 1986-10-16

BARD IRYFIX(TM) STOMA CAP

Applicant C.R. Bard, Inc.

K number K862631

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EXB 1986-06-16

COLOPLAST CONVEX RING

Applicant Coloplast A/S

K number K861070

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EXB 1986-04-16

DURAHESIVE PROTECTIVE BARRIER WIPE

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K855019

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EXB 1986-02-24

MEDI-WIPES UNITED ANTISEPTIC SKIN PREP

Applicant Pfizer, Inc.

K number K854726

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EXB 1986-02-04

DURAHESIVE WAFER WITH FLANGE

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K855018

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EXB 1986-01-14

CONFIDENT ODOR ELIMINATOR

Applicant Hallmark Industries, Inc.

K number K852471

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EXB 1985-06-27

OSTOMY BAGS ILEOSTOMY

Applicant Dbt Medical , Ltd.

K number K851680

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EXB 1985-06-27

OSTOMY BAGS COLOSTOMY

Applicant Dbt Medical , Ltd.

K number K851679

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EXB 1985-06-27

OSTOMY BAGS URETHEROSTOMY

Applicant Dbt Medical , Ltd.

K number K851678

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EXB 1985-06-24

STOMAHESIVE SKIN BARRIER STERILE

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K851840

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EXB 1985-06-12

JOHNSON & JOHNSON OSTOMY SIZE SELECTOR & BELT

Applicant Johnson & Johnson Professionals, Inc.

K number K852297

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EXB 1985-05-23

BARD PERISTOMAL PASTE

Applicant C.R. Bard, Inc.

K number K851398

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EXB 1985-05-23

DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY

Applicant Biolog, Inc.

K number K850751

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EXB 1985-05-23

DISPOSABLE UROSTOMY POUCH

Applicant Biolog, Inc.

K number K850750

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EXB 1985-01-18

UNITED SKIN BARRIERS

Applicant Pfizer, Inc.

K number K844938

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EXB 1985-01-08

COLOPLAST URO 2002 UROSTOMY SYSTEM

Applicant Coloplast A/S

K number K844685

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EXB 1984-11-29

JOHNSON & JOHN SON OSTOMY PASTE PROTECTIVWE SKIN

Applicant Johnson & Johnson Professionals, Inc.

K number K844406

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EXB 1984-11-29

UNITED SKIN BARRIERS

Applicant Howmedica Corp.

K number K844046

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EXB 1984-10-01

SUR-FIT IRRIGATION ADAPTER FACEPLATE

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K842398

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EXB 1984-09-10

OSTOMY OR UROSTOMY ABDOMINAL BELT OS

Applicant Atlas Surgical Belt Co., Inc.

K number K842119

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EXB 1984-07-09

OSTOMY FREEDOM KIT

Applicant Ellenberg Assoc.

K number K841173

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EXB 1984-05-07

SWEEN-A-PEEL PERISTOMAL WAFERS

Applicant Sween Corp.

K number K840723

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EXB 1984-05-02

ACTIVE LIFE ONE-PIECE CLOSED-END POUCH

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K840568

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EXB 1984-05-02

ACTIVE LIFE ONE-PIECE STOMA CAP

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K840567

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EXB 1984-05-02

COMFEEL PROTECTIVE FILM

Applicant Coloplast A/S

K number K833567

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EXB 1984-04-04

BANGORT LIFESTYLE COLOSTOMY POUCHES

Applicant Howmedica Corp.

K number K841029

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EXB 1984-04-02

MC 2000 OSTOMY POUCHES

Applicant Coloplast A/S

K number K840269

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EXB 1984-04-02

FILTRODER FILTERS

Applicant Coloplast A/S

K number K840267

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EXB 1984-04-02

MC 2002 OSTOMY POUCHES & SKIN FLANGES

Applicant Coloplast A/S

K number K840265

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EXB 1984-02-04

SUR-FIT UROSTOMY POUCH W/ACCUSEAL

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K840166

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EXB 1984-02-04

BARD KARAYA GUM WASHERS

Applicant C.R. Bard, Inc.

K number K834575

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EXB 1984-01-30

STERILE DRAINAGE SYSTEM

Applicant Coloplast A/S

K number K833571

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EXB 1984-01-30

COMFEEL PASTE

Applicant Coloplast A/S

K number K833565

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EXB 1983-12-27

COMFEEL BARRIER CREAM

Applicant Coloplast A/S

K number K833569

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EXB 1983-12-27

COMFEEL CLEANSER

Applicant Coloplast A/S

K number K833566

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EXB 1983-11-28

ACTIVE LIFE

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K833625

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EXB 1983-07-19

COLOSTOMY BAG

Applicant C & D Colostomy Pad Corp.

K number K830841

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EXB 1983-04-12

SUR-FIT FLEXIBLE

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K830945

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EXB 1982-07-02

BARD PROTECTIVE BARRIER FILM

Applicant C.R. Bard, Inc.

K number K821271

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EXB 1982-06-24

HOLLISTER CATHETER ACCESS. PORT

Applicant Hollister, Inc.

K number K821680

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EXB 1982-03-10

DEEP CONVEX FACE PLATE

Applicant Smith'S Ostomy Products, Inc.

K number K820493

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EXB 1982-02-18

LAMINATED KARAYA GUM WASHERS

Applicant Atlantic Surgical

K number K820167

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EXB 1981-12-14

FECAL INCONTINENCE COLLATOR

Applicant Hollister, Inc.

K number K813270

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EXB 1981-12-03

TWO PIECE OSTOMY SYSTEM

Applicant Hollister, Inc.

K number K813269

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EXB 1981-11-17

WOUND DRAINAGE MANAGEMENT SYSTEMS

Applicant Howmedica Corp.

K number K813080

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EXB 1981-09-23

CANCEL

Applicant Bio Systems, Inc.

K number K812582

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EXB 1981-06-16

SUR-FIT LOOP OSTOMY O.R. SET

Applicant E. R. Squibb & Sons, Inc.

K number K811240

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EXB 1981-06-09

ECONOMY OPEN END DRAINAGE BAG

Applicant Economy Plus

K number K811300

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EXB 1981-06-09

SUR-FIT DISPOSABLE CONVEX INSERT

Applicant E. R. Squibb & Sons, Inc.

K number K811239

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EXB 1981-06-02

FORMULATION CHANGE IN UNITED SKIN BARR

Applicant Howmedica Corp.

K number K810726

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EXB 1981-05-21

SUR-FIT DISPOSABLE FANGE CAP

Applicant E. R. Squibb & Sons, Inc.

K number K811163

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EXB 1981-04-17

DRAINING-WOUND MGMT. SYSTEM

Applicant Johnson & Johnson Professionals, Inc.

K number K810812

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EXB 1981-04-07

HOLLISEAL OSTOMY SKIN BARRIER

Applicant Hollister, Inc.

K number K810807

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EXB 1981-04-07

HOLLISTER SKIN BARRIER B

Applicant Hollister, Inc.

K number K810710

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EXB 1981-04-07

HOLLISTER SKIN BARRIER A

Applicant Hollister, Inc.

K number K810709

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EXB 1980-12-22

ADHESIVE PERISTOMAL COVERING W/WO CONN.

Applicant Johnson & Johnson Professionals, Inc.

K number K803082

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EXB 1980-12-22

VANCE UROSTOMY APPLIANCE

Applicant Vance Products, Inc.

K number K803048

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EXB 1980-11-12

CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON

Applicant Johnson & Johnson Professionals, Inc.

K number K802677

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EXB 1980-10-31

OSTOMATE THIRD HAND

Applicant Smith'S Ostomy Products, Inc.

K number K802424

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EXB 1980-09-09

SUR-FIT SYSTEM STERILE O.R. SETS

Applicant E. R. Squibb & Sons, Inc.

K number K801703

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EXB 1980-08-27

SUR-FIT SYSTEM PRE-OPERATION SET

Applicant E. R. Squibb & Sons, Inc.

K number K801702

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EXB 1980-08-13

HOLLISTER KARAYA SEAL RING

Applicant Hollister, Inc.

K number K801503

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EXB 1980-07-28

SUPER BANISH DEODORANT

Applicant Howmedica Corp.

K number K801471

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EXB 1980-05-08

STOMAHESIVE STERILE WAFER

Applicant Squibb & Sons, Inc.

K number K800750

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EXB 1980-04-08

SUR-FIT UROSTOMY POUCH & URINARY BAG

Applicant E. R. Squibb & Sons, Inc.

K number K800495

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EXB 1979-12-20

STOMAHESIVE POWDER

Applicant E. R. Squibb & Sons, Inc.

K number K792382

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EXB 1979-12-10

BONGORT ODOR BARRIER DRAIN

Applicant Howmedica Corp.

K number K792381

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EXB 1979-11-13

FEATHER-LITE URINARY DIV. POUCH

Applicant Howmedica Corp.

K number K792139

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EXB 1979-10-26

HOLLISTER STOMA POUCH WITH MICRO ADHES

Applicant Hollister, Inc.

K number K791535

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EXB 1979-10-26

HOLLISTER STOMA POUCH SKIN BARRIER

Applicant Hollister, Inc.

K number K791526

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EXB 1979-10-26

HOLLISTER KARAYA PASTE

Applicant Hollister, Inc.

K number K791525

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EXB 1979-10-09

HOLLISTER UROSTOMY POUCH

Applicant Hollister, Inc.

K number K791534

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EXB 1979-10-02

COLOPLAST CARBON GAS FILTER

Applicant C.R. Bard, Inc.

K number K791581

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EXB 1978-09-20

OSTOMY APPLIANCE W/DEODORIZING FILTER

Applicant Hollister, Inc.

K number K781373

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EXB 1978-08-18

OSTOMY APPLIANCE BELT

Applicant E. R. Squibb & Sons, Inc.

K number K781088

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EXB 1978-08-17

K-Z CONCENTRATE

Applicant K-Zyme Labs, Inc.

K number K781011

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EXB 1978-05-16

ILEX STOMA SEAL AND PROTECTIVE CREAM

Applicant Virgil Pichierri

K number K780473

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EXB 1978-04-21

SNAP-FIT

Applicant E. R. Squibb & Sons, Inc.

K number K780511

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EXB 1978-04-21

ACTIVE-LIFE

Applicant E. R. Squibb & Sons, Inc.

K number K780454

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EXB 1977-09-30

COLORPLAST TRANSVERSE SYSTEM

Applicant C.R. Bard, Inc.

K number K771775

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EXB 1977-04-15

STOMA BAG W/SKIN BARRIER SEAL RING

Applicant Hollister, Inc.

K number K770439

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EXB 1977-02-01

STOMA BAGS W/MICROPOROUS ADHESIVE

Applicant Hollister, Inc.

K number K770178

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EXB 1976-12-09

RECTAL TUBE DEVICE

Applicant Van Sickle Plastics Co.

K number K760886

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EXB 1976-12-02

BONGORT ILEOSTOMY POUCH

Applicant Howmedica Corp.

K number K760878

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EXB 1976-11-23

SILASTIC ILEAL RESERVOIR CATHETER

Applicant Dow Corning Corp. Healthcare Industries Materials

K number K760860

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