Collector, Ostomy
FDA product code EXB · Class I (low risk) · 21 CFR 876.5900 · Gastroenterology, Urology
102510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Hollister, Inc. 14
- Coloplast A/S 11
- E. R. Squibb & Sons, Inc. 10
- Howmedica Corp. 9
- Convatec, A Division of E.R. Squibb & Sons 9
- C.R. Bard, Inc. 6
- Johnson & Johnson Professionals, Inc. 5
- John F. Greer Co., Inc. 3
- Dbt Medical , Ltd. 3
- Pfizer, Inc. 2
- Biolog, Inc. 2
- Cdc Products Corp. 2
- Smith'S Ostomy Products, Inc. 2
- Arnold Technologies 2
- Economy Plus 1
- Bio Systems, Inc. 1
- Vance Products Incorporated 1
- Coloplast Corp. 1
- Squibb & Sons, Inc. 1
- Van Sickle Plastics Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252140 | Heylo SystemEXB · Traditional | Coloplast Corp. | 10/06/2025SE |
| K181643 | SmartBag (SmartPouch)EXB · Traditional | 11 Health Technologies Limited | 11/16/2018SE |
| K140938 | Ostom-I AlertEXB · Traditional | 11 Health and Technologies, LLC | 10/10/2014SE |
| K922730 | Lake Ostomy Care SetEXB · Traditional | Lake Medical Products, Inc. | 12/30/1993SESK |
| K882878 | Odor-End Emergency Clean Up PowderEXB · Traditional | Cdc Products Corp. | 12/08/1988SE |
| K881636 | Conseal Colostomy Continence System (One-Piece)EXB · Traditional | Coloplast A/S | 07/13/1988SE |
| K880306 | Emergency-Clean Up(Tm) EcpEXB · Traditional | Cdc Products Corp. | 05/20/1988SE |
| K872294 | Combination Nite Drainage UnitEXB · Traditional | Arnold Technologies | 12/29/1987SE |
| K873929 | 'Catch-It' or Fecal Containment DeviceEXB · Traditional | Midwest Medical Co. | 12/03/1987SE |
| K871526 | Odor-Safe(Tm)(Liquid) Odor-Safe(Tm) PowderEXB · Traditional | Cox Family Laboratories, Inc. | 10/13/1987SE |
| K871738 | Osto-PureEXB · Traditional | Clearchem Corp. | 08/12/1987SE |
| K871628 | Palex (R) OstomyEXB · Traditional | Industrias Palex C/O Dma Med-Chem Corp. | 07/08/1987SE |
| K870577 | E-Z LoopEXB · Traditional | John F. Greer Co., Inc. | 04/17/1987SE |
| K870531 | Ez Tac FilterEXB · Traditional | John F. Greer Co., Inc. | 04/10/1987SE |
| K870136 | Personal PunchEXB · Traditional | Arnold Technologies | 04/01/1987SE |
| K864189 | Ultra-Gel - #4083EXB · Traditional | John F. Greer Co., Inc. | 12/04/1986SE |
| K862631 | Bard Iryfix(Tm) Stoma CapEXB · Traditional | C.R. Bard, Inc. | 10/16/1986SE |
| K861070 | Coloplast Convex RingEXB · Traditional | Coloplast A/S | 06/16/1986SE |
| K855019 | Durahesive Protective Barrier WipeEXB · Traditional | Convatec, A Division of E.R. Squibb & Sons | 04/16/1986SE |
| K854726 | Medi-Wipes United Antiseptic Skin PrepEXB · Traditional | Pfizer, Inc. | 02/24/1986SE |
| K855018 | Durahesive Wafer with FlangeEXB · Traditional | Convatec, A Division of E.R. Squibb & Sons | 02/04/1986SE |
| K852471 | Confident Odor EliminatorEXB · Traditional | Hallmark Industries, Inc. | 01/14/1986SE |
| K851680 | Ostomy Bags IleostomyEXB · Traditional | Dbt Medical , Ltd. | 06/27/1985SE |
| K851679 | Ostomy Bags ColostomyEXB · Traditional | Dbt Medical , Ltd. | 06/27/1985SE |
| K851678 | Ostomy Bags UretherostomyEXB · Traditional | Dbt Medical , Ltd. | 06/27/1985SE |
| K851840 | Stomahesive Skin Barrier SterileEXB · Traditional | Convatec, A Division of E.R. Squibb & Sons | 06/24/1985SE |
| K852297 | Johnson & Johnson Ostomy Size Selector & BeltEXB · Traditional | Johnson & Johnson Professionals, Inc. | 06/12/1985SE |
| K851398 | Bard Peristomal PasteEXB · Traditional | C.R. Bard, Inc. | 05/23/1985SE |
| K850751 | Dispos. Drainabel Pouch for Ileostomy/ColostomyEXB · Traditional | Biolog, Inc. | 05/23/1985SE |
| K850750 | Disposable Urostomy PouchEXB · Traditional | Biolog, Inc. | 05/23/1985SE |
| K844938 | United Skin BarriersEXB · Traditional | Pfizer, Inc. | 01/18/1985SE |
| K844685 | Coloplast Uro 2002 Urostomy SystemEXB · Traditional | Coloplast A/S | 01/08/1985SE |
| K844406 | Johnson & John Son Ostomy Paste Protectivwe SkinEXB · Traditional | Johnson & Johnson Professionals, Inc. | 11/29/1984SE |
| K844046 | United Skin BarriersEXB · Traditional | Howmedica Corp. | 11/29/1984SE |
| K842398 | Sur-Fit Irrigation Adapter FaceplateEXB · Traditional | Convatec, A Division of E.R. Squibb & Sons | 10/01/1984SE |
| K842119 | Ostomy or Urostomy Abdominal Belt OsEXB · Traditional | Atlas Surgical Belt Co., Inc. | 09/10/1984SE |
| K841173 | Ostomy Freedom KitEXB · Traditional | Ellenberg Assoc. | 07/09/1984SE |
| K840723 | Sween-A-Peel Peristomal WafersEXB · Traditional | Sween Corp. | 05/07/1984SE |
| K840568 | Active Life One-Piece Closed-End PouchEXB · Traditional | Convatec, A Division of E.R. Squibb & Sons | 05/02/1984SE |
| K840567 | Active Life One-Piece Stoma CapEXB · Traditional | Convatec, A Division of E.R. Squibb & Sons | 05/02/1984SE |
| K833567 | Comfeel Protective FilmEXB · Traditional | Coloplast A/S | 05/02/1984SE |
| K841029 | Bangort Lifestyle Colostomy PouchesEXB · Traditional | Howmedica Corp. | 04/04/1984SE |
| K840269 | MC 2000 Ostomy PouchesEXB · Traditional | Coloplast A/S | 04/02/1984SE |
| K840267 | Filtroder FiltersEXB · Traditional | Coloplast A/S | 04/02/1984SE |
| K840265 | MC 2002 Ostomy Pouches & Skin FlangesEXB · Traditional | Coloplast A/S | 04/02/1984SE |
| K840166 | Sur-Fit Urostomy Pouch W/AccusealEXB · Traditional | Convatec, A Division of E.R. Squibb & Sons | 02/04/1984SE |
| K834575 | Bard Karaya Gum WashersEXB · Traditional | C.R. Bard, Inc. | 02/04/1984SE |
| K833571 | Sterile Drainage SystemEXB · Traditional | Coloplast A/S | 01/30/1984SE |
| K833565 | Comfeel PasteEXB · Traditional | Coloplast A/S | 01/30/1984SE |
| K833569 | Comfeel Barrier CreamEXB · Traditional | Coloplast A/S | 12/27/1983SE |
| K833566 | Comfeel CleanserEXB · Traditional | Coloplast A/S | 12/27/1983SE |
| K833625 | Active LifeEXB · Traditional | Convatec, A Division of E.R. Squibb & Sons | 11/28/1983SE |
| K830841 | Colostomy BagEXB · Traditional | C & D Colostomy Pad Corp. | 07/19/1983SE |
| K830945 | Sur-Fit FlexibleEXB · Traditional | Convatec, A Division of E.R. Squibb & Sons | 04/12/1983SE |
| K821271 | Bard Protective Barrier FilmEXB · Traditional | C.R. Bard, Inc. | 07/02/1982SE |
| K821680 | Hollister Catheter Access. PortEXB · Traditional | Hollister, Inc. | 06/24/1982SE |
| K820493 | Deep Convex Face PlateEXB · Traditional | Smith'S Ostomy Products, Inc. | 03/10/1982SE |
| K820167 | Laminated Karaya Gum WashersEXB · Traditional | Atlantic Surgical | 02/18/1982SE |
| K813270 | Fecal Incontinence CollatorEXB · Traditional | Hollister, Inc. | 12/14/1981SE |
| K813269 | Two Piece Ostomy SystemEXB · Traditional | Hollister, Inc. | 12/03/1981SE |
| K813080 | Wound Drainage Management SystemsEXB · Traditional | Howmedica Corp. | 11/17/1981SE |
| K812582 | CancelEXB · Traditional | Bio Systems, Inc. | 09/23/1981SE |
| K811240 | Sur-Fit Loop Ostomy O.R. SetEXB · Traditional | E. R. Squibb & Sons, Inc. | 06/16/1981SE |
| K811300 | Economy Open End Drainage BagEXB · Traditional | Economy Plus | 06/09/1981SE |
| K811239 | Sur-Fit Disposable Convex InsertEXB · Traditional | E. R. Squibb & Sons, Inc. | 06/09/1981SE |
| K810726 | Formulation Change in United Skin BarrEXB · Traditional | Howmedica Corp. | 06/02/1981SE |
| K811163 | Sur-Fit Disposable Fange CapEXB · Traditional | E. R. Squibb & Sons, Inc. | 05/21/1981SE |
| K810812 | Draining-Wound Mgmt. SystemEXB · Traditional | Johnson & Johnson Professionals, Inc. | 04/17/1981SE |
| K810807 | Holliseal Ostomy Skin BarrierEXB · Traditional | Hollister, Inc. | 04/07/1981SE |
| K810710 | Hollister Skin Barrier BEXB · Traditional | Hollister, Inc. | 04/07/1981SE |
| K810709 | Hollister Skin Barrier aEXB · Traditional | Hollister, Inc. | 04/07/1981SE |
| K803082 | Adhesive Peristomal Covering W/Wo Conn.EXB · Traditional | Johnson & Johnson Professionals, Inc. | 12/22/1980SE |
| K803048 | Vance Urostomy ApplianceEXB · Traditional | Vance Products, Inc. | 12/22/1980SE |
| K802677 | Closed-End/Open-End Colostomy Pch. W/ConEXB · Traditional | Johnson & Johnson Professionals, Inc. | 11/12/1980SE |
| K802424 | Ostomate Third HandEXB · Traditional | Smith'S Ostomy Products, Inc. | 10/31/1980SE |
| K801703 | Sur-Fit System Sterile O.R. SetsEXB · Traditional | E. R. Squibb & Sons, Inc. | 09/09/1980SE |
| K801702 | Sur-Fit System Pre-Operation SetEXB · Traditional | E. R. Squibb & Sons, Inc. | 08/27/1980SE |
| K801503 | Hollister Karaya Seal RingEXB · Traditional | Hollister, Inc. | 08/13/1980SE |
| K801471 | Super Banish DeodorantEXB · Traditional | Howmedica Corp. | 07/28/1980SE |
| K800750 | Stomahesive Sterile WaferEXB · Traditional | Squibb & Sons, Inc. | 05/08/1980SE |
| K800495 | Sur-Fit Urostomy Pouch & Urinary BagEXB · Traditional | E. R. Squibb & Sons, Inc. | 04/08/1980SE |
| K792382 | Stomahesive PowderEXB · Traditional | E. R. Squibb & Sons, Inc. | 12/20/1979SE |
| K792381 | Bongort Odor Barrier DrainEXB · Traditional | Howmedica Corp. | 12/10/1979SE |
| K792139 | Feather-Lite Urinary Div. PouchEXB · Traditional | Howmedica Corp. | 11/13/1979SE |
| K791535 | Hollister Stoma Pouch with Micro AdhesEXB · Traditional | Hollister, Inc. | 10/26/1979SE |
| K791526 | Hollister Stoma Pouch Skin BarrierEXB · Traditional | Hollister, Inc. | 10/26/1979SE |
| K791525 | Hollister Karaya PasteEXB · Traditional | Hollister, Inc. | 10/26/1979SE |
| K791534 | Hollister Urostomy PouchEXB · Traditional | Hollister, Inc. | 10/09/1979SE |
| K791581 | Coloplast Carbon Gas FilterEXB · Traditional | C.R. Bard, Inc. | 10/02/1979SE |
| K781373 | Ostomy Appliance W/Deodorizing FilterEXB · Traditional | Hollister, Inc. | 09/20/1978SE |
| K781088 | Ostomy Appliance BeltEXB · Traditional | E. R. Squibb & Sons, Inc. | 08/18/1978SE |
| K781011 | K-Z ConcentrateEXB · Traditional | K-Zyme Labs, Inc. | 08/17/1978SE |
| K780473 | Ilex Stoma Seal and Protective CreamEXB · Traditional | Virgil Pichierri | 05/16/1978SE |
| K780511 | Snap-FitEXB · Traditional | E. R. Squibb & Sons, Inc. | 04/21/1978SE |
| K780454 | Active-LifeEXB · Traditional | E. R. Squibb & Sons, Inc. | 04/21/1978SE |
| K771775 | Colorplast Transverse SystemEXB · Traditional | C.R. Bard, Inc. | 09/30/1977SE |
| K770439 | Stoma Bag W/Skin Barrier Seal RingEXB · Traditional | Hollister, Inc. | 04/15/1977SE |
| K770178 | Stoma Bags W/Microporous AdhesiveEXB · Traditional | Hollister, Inc. | 02/01/1977SE |
| K760886 | Rectal Tube DeviceEXB · Traditional | Van Sickle Plastics Co. | 12/09/1976SE |
| K760878 | Bongort Ileostomy PouchEXB · Traditional | Howmedica Corp. | 12/02/1976SE |
| K760860 | Silastic Ileal Reservoir CatheterEXB · Traditional | Dow Corning Corp. Healthcare Industries Materials | 11/23/1976SE |
| K760735 | Bongort Special Odorproof DrainEXB · Traditional | Howmedica Corp. | 10/15/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3174-2011 | Coloplast Corp.-MN 06093, Country of origin: DK ( SenSura 19011 Post-Op, ostomy bag with…On July 19, 2011 Coloplast became aware of the failure or routine sterility testing for one lot of SenSuera… | Coloplast Manufacturing US, LLC | 07/27/2011Terminated |
| Z-0013-2012 | Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm)…Post-operative kits 57 mm may contain 70 mm pouches. | Convatec Inc. | 06/22/2011Terminated |
| Z-1610-2011 | Natura Durahesive ConvaTec Moldable Technology Post-Operative/Surgical System (57mm), 2…Natura Durahesive ConvaTec Moldable Technology Post Operative/Surgical System (57mm) units may contain… | Convatec Inc. | 02/01/2011Terminated |
| Z-1314-2008 | GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories…Mislabeled: The carton label reads "For postsurgical use following a urostomy procedure." It should read… | ConvaTec | 03/07/2008Terminated |
| Z-1179-2008 | Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy…Mislabeled: The market unit carton label reads 5/8 - 1 inch, and it should read 5/16 - 1 inch. The metric… | ConvaTec | 02/14/2008Terminated |