FDA Product Code
FDA Product Code EXB — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5900
510(k) Clearances — 102 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252140 | Heylo System | Coloplast Corp. | 2025-10-06 | Traditional | PDF ↗ |
| K181643 | SmartBag (SmartPouch) | 11 Health Technologies Limited | 2018-11-16 | Traditional | PDF ↗ |
| K140938 | OSTOM-I ALERT | 11 Health and Technologies, LLC | 2014-10-10 | Traditional | PDF ↗ |
| K922730 | LAKE OSTOMY CARE SET | Lake Medical Products, Inc. | 1993-12-30 | Traditional | PDF ↗ |
| K882878 | ODOR-END EMERGENCY CLEAN UP POWDER | Cdc Products Corp. | 1988-12-08 | Traditional | PDF ↗ |
| K881636 | CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) | Coloplast A/S | 1988-07-13 | Traditional | PDF ↗ |
| K880306 | EMERGENCY-CLEAN UP(TM) ECP | Cdc Products Corp. | 1988-05-20 | Traditional | PDF ↗ |
| K872294 | COMBINATION NITE DRAINAGE UNIT | Arnold Technologies | 1987-12-29 | Traditional | PDF ↗ |
| K873929 | 'CATCH-IT' OR FECAL CONTAINMENT DEVICE | Midwest Medical Co. | 1987-12-03 | Traditional | PDF ↗ |
| K871526 | ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER | Cox Family Laboratories, Inc. | 1987-10-13 | Traditional | PDF ↗ |
| K871738 | OSTO-PURE | Clearchem Corp. | 1987-08-12 | Traditional | PDF ↗ |
| K871628 | PALEX (R) OSTOMY | Industrias Palex C/O Dma Med-Chem Corp. | 1987-07-08 | Traditional | PDF ↗ |
| K870577 | E-Z LOOP | John F. Greer Co., Inc. | 1987-04-17 | Traditional | PDF ↗ |
| K870531 | EZ TAC FILTER | John F. Greer Co., Inc. | 1987-04-10 | Traditional | PDF ↗ |
| K870136 | PERSONAL PUNCH | Arnold Technologies | 1987-04-01 | Traditional | PDF ↗ |
| K864189 | ULTRA-GEL - #4083 | John F. Greer Co., Inc. | 1986-12-04 | Traditional | PDF ↗ |
| K862631 | BARD IRYFIX(TM) STOMA CAP | C.R. Bard, Inc. | 1986-10-16 | Traditional | PDF ↗ |
| K861070 | COLOPLAST CONVEX RING | Coloplast A/S | 1986-06-16 | Traditional | PDF ↗ |
| K855019 | DURAHESIVE PROTECTIVE BARRIER WIPE | Convatec, A Division of E.R. Squibb & Sons | 1986-04-16 | Traditional | PDF ↗ |
| K854726 | MEDI-WIPES UNITED ANTISEPTIC SKIN PREP | Pfizer, Inc. | 1986-02-24 | Traditional | PDF ↗ |
| K855018 | DURAHESIVE WAFER WITH FLANGE | Convatec, A Division of E.R. Squibb & Sons | 1986-02-04 | Traditional | PDF ↗ |
| K852471 | CONFIDENT ODOR ELIMINATOR | Hallmark Industries, Inc. | 1986-01-14 | Traditional | PDF ↗ |
| K851680 | OSTOMY BAGS ILEOSTOMY | Dbt Medical , Ltd. | 1985-06-27 | Traditional | PDF ↗ |
| K851678 | OSTOMY BAGS URETHEROSTOMY | Dbt Medical , Ltd. | 1985-06-27 | Traditional | PDF ↗ |
| K851679 | OSTOMY BAGS COLOSTOMY | Dbt Medical , Ltd. | 1985-06-27 | Traditional | PDF ↗ |
| K851840 | STOMAHESIVE SKIN BARRIER STERILE | Convatec, A Division of E.R. Squibb & Sons | 1985-06-24 | Traditional | PDF ↗ |
| K852297 | JOHNSON & JOHNSON OSTOMY SIZE SELECTOR & BELT | Johnson & Johnson Professionals, Inc. | 1985-06-12 | Traditional | PDF ↗ |
| K850751 | DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY | Biolog, Inc. | 1985-05-23 | Traditional | PDF ↗ |
| K851398 | BARD PERISTOMAL PASTE | C.R. Bard, Inc. | 1985-05-23 | Traditional | PDF ↗ |
| K850750 | DISPOSABLE UROSTOMY POUCH | Biolog, Inc. | 1985-05-23 | Traditional | PDF ↗ |
| K844938 | UNITED SKIN BARRIERS | Pfizer, Inc. | 1985-01-18 | Traditional | PDF ↗ |
| K844685 | COLOPLAST URO 2002 UROSTOMY SYSTEM | Coloplast A/S | 1985-01-08 | Traditional | PDF ↗ |
| K844046 | UNITED SKIN BARRIERS | Howmedica Corp. | 1984-11-29 | Traditional | PDF ↗ |
| K844406 | JOHNSON & JOHN SON OSTOMY PASTE PROTECTIVWE SKIN | Johnson & Johnson Professionals, Inc. | 1984-11-29 | Traditional | PDF ↗ |
| K842398 | SUR-FIT IRRIGATION ADAPTER FACEPLATE | Convatec, A Division of E.R. Squibb & Sons | 1984-10-01 | Traditional | PDF ↗ |
| K842119 | OSTOMY OR UROSTOMY ABDOMINAL BELT OS | Atlas Surgical Belt Co., Inc. | 1984-09-10 | Traditional | PDF ↗ |
| K841173 | OSTOMY FREEDOM KIT | Ellenberg Assoc. | 1984-07-09 | Traditional | PDF ↗ |
| K840723 | SWEEN-A-PEEL PERISTOMAL WAFERS | Sween Corp. | 1984-05-07 | Traditional | PDF ↗ |
| K840568 | ACTIVE LIFE ONE-PIECE CLOSED-END POUCH | Convatec, A Division of E.R. Squibb & Sons | 1984-05-02 | Traditional | PDF ↗ |
| K840567 | ACTIVE LIFE ONE-PIECE STOMA CAP | Convatec, A Division of E.R. Squibb & Sons | 1984-05-02 | Traditional | PDF ↗ |
| K833567 | COMFEEL PROTECTIVE FILM | Coloplast A/S | 1984-05-02 | Traditional | PDF ↗ |
| K841029 | BANGORT LIFESTYLE COLOSTOMY POUCHES | Howmedica Corp. | 1984-04-04 | Traditional | PDF ↗ |
| K840265 | MC 2002 OSTOMY POUCHES & SKIN FLANGES | Coloplast A/S | 1984-04-02 | Traditional | PDF ↗ |
| K840267 | FILTRODER FILTERS | Coloplast A/S | 1984-04-02 | Traditional | PDF ↗ |
| K840269 | MC 2000 OSTOMY POUCHES | Coloplast A/S | 1984-04-02 | Traditional | PDF ↗ |
| K834575 | BARD KARAYA GUM WASHERS | C.R. Bard, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K840166 | SUR-FIT UROSTOMY POUCH W/ACCUSEAL | Convatec, A Division of E.R. Squibb & Sons | 1984-02-04 | Traditional | PDF ↗ |
| K833565 | COMFEEL PASTE | Coloplast A/S | 1984-01-30 | Traditional | PDF ↗ |
| K833571 | STERILE DRAINAGE SYSTEM | Coloplast A/S | 1984-01-30 | Traditional | PDF ↗ |
| K833566 | COMFEEL CLEANSER | Coloplast A/S | 1983-12-27 | Traditional | PDF ↗ |
| K833569 | COMFEEL BARRIER CREAM | Coloplast A/S | 1983-12-27 | Traditional | PDF ↗ |
| K833625 | ACTIVE LIFE | Convatec, A Division of E.R. Squibb & Sons | 1983-11-28 | Traditional | PDF ↗ |
| K830841 | COLOSTOMY BAG | C & D Colostomy Pad Corp. | 1983-07-19 | Traditional | PDF ↗ |
| K830945 | SUR-FIT FLEXIBLE | Convatec, A Division of E.R. Squibb & Sons | 1983-04-12 | Traditional | PDF ↗ |
| K821271 | BARD PROTECTIVE BARRIER FILM | C.R. Bard, Inc. | 1982-07-02 | Traditional | PDF ↗ |
| K821680 | HOLLISTER CATHETER ACCESS. PORT | Hollister, Inc. | 1982-06-24 | Traditional | PDF ↗ |
| K820493 | DEEP CONVEX FACE PLATE | Smith'S Ostomy Products, Inc. | 1982-03-10 | Traditional | PDF ↗ |
| K820167 | LAMINATED KARAYA GUM WASHERS | Atlantic Surgical | 1982-02-18 | Traditional | PDF ↗ |
| K813270 | FECAL INCONTINENCE COLLATOR | Hollister, Inc. | 1981-12-14 | Traditional | PDF ↗ |
| K813269 | TWO PIECE OSTOMY SYSTEM | Hollister, Inc. | 1981-12-03 | Traditional | PDF ↗ |
| K813080 | WOUND DRAINAGE MANAGEMENT SYSTEMS | Howmedica Corp. | 1981-11-17 | Traditional | PDF ↗ |
| K812582 | CANCEL | Bio Systems, Inc. | 1981-09-23 | Traditional | PDF ↗ |
| K811240 | SUR-FIT LOOP OSTOMY O.R. SET | E. R. Squibb & Sons, Inc. | 1981-06-16 | Traditional | PDF ↗ |
| K811300 | ECONOMY OPEN END DRAINAGE BAG | Economy Plus | 1981-06-09 | Traditional | PDF ↗ |
| K811239 | SUR-FIT DISPOSABLE CONVEX INSERT | E. R. Squibb & Sons, Inc. | 1981-06-09 | Traditional | PDF ↗ |
| K810726 | FORMULATION CHANGE IN UNITED SKIN BARR | Howmedica Corp. | 1981-06-02 | Traditional | PDF ↗ |
| K811163 | SUR-FIT DISPOSABLE FANGE CAP | E. R. Squibb & Sons, Inc. | 1981-05-21 | Traditional | PDF ↗ |
| K810812 | DRAINING-WOUND MGMT. SYSTEM | Johnson & Johnson Professionals, Inc. | 1981-04-17 | Traditional | PDF ↗ |
| K810807 | HOLLISEAL OSTOMY SKIN BARRIER | Hollister, Inc. | 1981-04-07 | Traditional | PDF ↗ |
| K810710 | HOLLISTER SKIN BARRIER B | Hollister, Inc. | 1981-04-07 | Traditional | PDF ↗ |
| K810709 | HOLLISTER SKIN BARRIER A | Hollister, Inc. | 1981-04-07 | Traditional | PDF ↗ |
| K803082 | ADHESIVE PERISTOMAL COVERING W/WO CONN. | Johnson & Johnson Professionals, Inc. | 1980-12-22 | Traditional | PDF ↗ |
| K803048 | VANCE UROSTOMY APPLIANCE | Vance Products, Inc. | 1980-12-22 | Traditional | PDF ↗ |
| K802677 | CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON | Johnson & Johnson Professionals, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K802424 | OSTOMATE THIRD HAND | Smith'S Ostomy Products, Inc. | 1980-10-31 | Traditional | PDF ↗ |
| K801703 | SUR-FIT SYSTEM STERILE O.R. SETS | E. R. Squibb & Sons, Inc. | 1980-09-09 | Traditional | PDF ↗ |
| K801702 | SUR-FIT SYSTEM PRE-OPERATION SET | E. R. Squibb & Sons, Inc. | 1980-08-27 | Traditional | PDF ↗ |
| K801503 | HOLLISTER KARAYA SEAL RING | Hollister, Inc. | 1980-08-13 | Traditional | PDF ↗ |
| K801471 | SUPER BANISH DEODORANT | Howmedica Corp. | 1980-07-28 | Traditional | PDF ↗ |
| K800750 | STOMAHESIVE STERILE WAFER | Squibb & Sons, Inc. | 1980-05-08 | Traditional | PDF ↗ |
| K800495 | SUR-FIT UROSTOMY POUCH & URINARY BAG | E. R. Squibb & Sons, Inc. | 1980-04-08 | Traditional | PDF ↗ |
| K792382 | STOMAHESIVE POWDER | E. R. Squibb & Sons, Inc. | 1979-12-20 | Traditional | PDF ↗ |
| K792381 | BONGORT ODOR BARRIER DRAIN | Howmedica Corp. | 1979-12-10 | Traditional | PDF ↗ |
| K792139 | FEATHER-LITE URINARY DIV. POUCH | Howmedica Corp. | 1979-11-13 | Traditional | PDF ↗ |
| K791526 | HOLLISTER STOMA POUCH SKIN BARRIER | Hollister, Inc. | 1979-10-26 | Traditional | PDF ↗ |
| K791535 | HOLLISTER STOMA POUCH WITH MICRO ADHES | Hollister, Inc. | 1979-10-26 | Traditional | PDF ↗ |
| K791525 | HOLLISTER KARAYA PASTE | Hollister, Inc. | 1979-10-26 | Traditional | PDF ↗ |
| K791534 | HOLLISTER UROSTOMY POUCH | Hollister, Inc. | 1979-10-09 | Traditional | PDF ↗ |
| K791581 | COLOPLAST CARBON GAS FILTER | C.R. Bard, Inc. | 1979-10-02 | Traditional | PDF ↗ |
| K781373 | OSTOMY APPLIANCE W/DEODORIZING FILTER | Hollister, Inc. | 1978-09-20 | Traditional | PDF ↗ |
| K781088 | OSTOMY APPLIANCE BELT | E. R. Squibb & Sons, Inc. | 1978-08-18 | Traditional | PDF ↗ |
| K781011 | K-Z CONCENTRATE | K-Zyme Labs, Inc. | 1978-08-17 | Traditional | PDF ↗ |
| K780473 | ILEX STOMA SEAL AND PROTECTIVE CREAM | Virgil Pichierri | 1978-05-16 | Traditional | PDF ↗ |
| K780511 | SNAP-FIT | E. R. Squibb & Sons, Inc. | 1978-04-21 | Traditional | PDF ↗ |
| K780454 | ACTIVE-LIFE | E. R. Squibb & Sons, Inc. | 1978-04-21 | Traditional | PDF ↗ |
| K771775 | COLORPLAST TRANSVERSE SYSTEM | C.R. Bard, Inc. | 1977-09-30 | Traditional | PDF ↗ |
| K770439 | STOMA BAG W/SKIN BARRIER SEAL RING | Hollister, Inc. | 1977-04-15 | Traditional | PDF ↗ |
| K770178 | STOMA BAGS W/MICROPOROUS ADHESIVE | Hollister, Inc. | 1977-02-01 | Traditional | PDF ↗ |
| K760886 | RECTAL TUBE DEVICE | Van Sickle Plastics Co. | 1976-12-09 | Traditional | PDF ↗ |
| K760878 | BONGORT ILEOSTOMY POUCH | Howmedica Corp. | 1976-12-02 | Traditional | PDF ↗ |
Product code EXB · Class I · Gastroenterology, Urology. Data: openFDA.