Product code EXB
- Device name
- Collector, Ostomy
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.5900
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252140 | Heylo™ System | Coloplast Corp. | 2025-10-06 |
| K181643 | SmartBag (SmartPouch) | 11 Health Technologies Limited | 2018-11-16 |
| K140938 | OSTOM-I ALERT | 11 Health and Technologies, LLC | 2014-10-10 |
| K922730 | LAKE OSTOMY CARE SET | Lake Medical Products, Inc. | 1993-12-30 |
| K882878 | ODOR-END EMERGENCY CLEAN UP POWDER | Cdc Products Corp. | 1988-12-08 |
| K881636 | CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) | Coloplast A/S | 1988-07-13 |
| K880306 | EMERGENCY-CLEAN UP(TM) ECP | Cdc Products Corp. | 1988-05-20 |
| K872294 | COMBINATION NITE DRAINAGE UNIT | Arnold Technologies | 1987-12-29 |
| K873929 | 'CATCH-IT' OR FECAL CONTAINMENT DEVICE | Midwest Medical Co. | 1987-12-03 |
| K871526 | ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER | Cox Family Laboratories, Inc. | 1987-10-13 |
| K871738 | OSTO-PURE | Clearchem Corp. | 1987-08-12 |
| K871628 | PALEX (R) OSTOMY | Industrias Palex C/O Dma Med-Chem Corp. | 1987-07-08 |
| K870577 | E-Z LOOP | John F. Greer Co., Inc. | 1987-04-17 |
| K870531 | EZ TAC FILTER | John F. Greer Co., Inc. | 1987-04-10 |
| K870136 | PERSONAL PUNCH | Arnold Technologies | 1987-04-01 |
| K864189 | ULTRA-GEL - #4083 | John F. Greer Co., Inc. | 1986-12-04 |
| K862631 | BARD IRYFIX(TM) STOMA CAP | C.R. Bard, Inc. | 1986-10-16 |
| K861070 | COLOPLAST CONVEX RING | Coloplast A/S | 1986-06-16 |
| K855019 | DURAHESIVE PROTECTIVE BARRIER WIPE | Convatec, A Division of E.R. Squibb & Sons | 1986-04-16 |
| K854726 | MEDI-WIPES UNITED ANTISEPTIC SKIN PREP | Pfizer, Inc. | 1986-02-24 |
| K855018 | DURAHESIVE WAFER WITH FLANGE | Convatec, A Division of E.R. Squibb & Sons | 1986-02-04 |
| K852471 | CONFIDENT ODOR ELIMINATOR | Hallmark Industries, Inc. | 1986-01-14 |
| K851680 | OSTOMY BAGS ILEOSTOMY | Dbt Medical , Ltd. | 1985-06-27 |
| K851678 | OSTOMY BAGS URETHEROSTOMY | Dbt Medical , Ltd. | 1985-06-27 |
| K851679 | OSTOMY BAGS COLOSTOMY | Dbt Medical , Ltd. | 1985-06-27 |
| K851840 | STOMAHESIVE SKIN BARRIER STERILE | Convatec, A Division of E.R. Squibb & Sons | 1985-06-24 |
| K852297 | JOHNSON & JOHNSON OSTOMY SIZE SELECTOR & BELT | Johnson & Johnson Professionals, Inc. | 1985-06-12 |
| K851398 | BARD PERISTOMAL PASTE | C.R. Bard, Inc. | 1985-05-23 |
| K850750 | DISPOSABLE UROSTOMY POUCH | Biolog, Inc. | 1985-05-23 |
| K850751 | DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY | Biolog, Inc. | 1985-05-23 |
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|---|---|---|---|
| 09421905447225 | The Insides Neo | THE INSIDES COMPANY LIMITED | 2025-10-16 |
| 09421905447195 | The Insides Neo | THE INSIDES COMPANY LIMITED | 2023-05-26 |
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| 00610075037773 | Pouchkins | HOLLISTER INCORPORATED | 2018-01-01 |