Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart F — Therapeutic Devices](/submissions/GU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 876.5900](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5900) → EXB — Collector, Ostomy

# EXB · Collector, Ostomy

_Gastroenterology, Urology · 21 CFR 876.5900 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB

## Overview

- **Product Code:** EXB
- **Device Name:** Collector, Ostomy
- **Regulation:** [21 CFR 876.5900](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5900)
- **Device Class:** 1
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## Recent Cleared Devices (20 of 102)

Showing 20 most recent of 102 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K252140](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K252140.md) | Heylo™ System | Coloplast Corp. | Oct 6, 2025 | SESE |
| [K181643](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K181643.md) | SmartBag (SmartPouch) | 11 Health Technologies Limited | Nov 16, 2018 | SESE |
| [K140938](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K140938.md) | OSTOM-I ALERT | 11 Health and Technologies, LLC | Oct 10, 2014 | SESE |
| [K922730](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K922730.md) | LAKE OSTOMY CARE SET | Lake Medical Products, Inc. | Dec 30, 1993 | SESK |
| [K882878](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K882878.md) | ODOR-END EMERGENCY CLEAN UP POWDER | Cdc Products Corp. | Dec 8, 1988 | SESE |
| [K881636](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K881636.md) | CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) | Coloplast A/S | Jul 13, 1988 | SESE |
| [K880306](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K880306.md) | EMERGENCY-CLEAN UP(TM) ECP | Cdc Products Corp. | May 20, 1988 | SESE |
| [K872294](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K872294.md) | COMBINATION NITE DRAINAGE UNIT | Arnold Technologies | Dec 29, 1987 | SESE |
| [K873929](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K873929.md) | 'CATCH-IT' OR FECAL CONTAINMENT DEVICE | Midwest Medical Co. | Dec 3, 1987 | SESE |
| [K871526](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K871526.md) | ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER | Cox Family Laboratories, Inc. | Oct 13, 1987 | SESE |
| [K871738](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K871738.md) | OSTO-PURE | Clearchem Corp. | Aug 12, 1987 | SESE |
| [K871628](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K871628.md) | PALEX (R) OSTOMY | Industrias Palex C/O Dma Med-Chem Corp. | Jul 8, 1987 | SESE |
| [K870577](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K870577.md) | E-Z LOOP | John F. Greer Co., Inc. | Apr 17, 1987 | SESE |
| [K870531](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K870531.md) | EZ TAC FILTER | John F. Greer Co., Inc. | Apr 10, 1987 | SESE |
| [K870136](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K870136.md) | PERSONAL PUNCH | Arnold Technologies | Apr 1, 1987 | SESE |
| [K864189](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K864189.md) | ULTRA-GEL - #4083 | John F. Greer Co., Inc. | Dec 4, 1986 | SESE |
| [K862631](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K862631.md) | BARD IRYFIX(TM) STOMA CAP | C.R. Bard, Inc. | Oct 16, 1986 | SESE |
| [K861070](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K861070.md) | COLOPLAST CONVEX RING | Coloplast A/S | Jun 16, 1986 | SESE |
| [K855019](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K855019.md) | DURAHESIVE PROTECTIVE BARRIER WIPE | Convatec, A Division of E.R. Squibb & Sons | Apr 16, 1986 | SESE |
| [K854726](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K854726.md) | MEDI-WIPES UNITED ANTISEPTIC SKIN PREP | Pfizer, Inc. | Feb 24, 1986 | SESE |

## Top Applicants

- Hollister, Inc. — 14 clearances
- Coloplast A/S — 11 clearances
- E. R. Squibb & Sons, Inc. — 10 clearances
- Convatec, A Division of E.R. Squibb & Sons — 9 clearances
- Howmedica Corp. — 9 clearances

---

**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB)

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