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) → GDS — Bag, Stomal

# GDS · Bag, Stomal

_Gastroenterology, Urology · 21 CFR 876.5900 · Class 1_

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

## Overview

- **Product Code:** GDS
- **Device Name:** Bag, Stomal
- **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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K883023](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/GDS/K883023.md) | MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND | Mentor Corp. | Sep 29, 1988 | SESE |
| [K871313](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/GDS/K871313.md) | ULTRA-FRESH DEODORANT | Mentor Corp. | Mar 2, 1988 | SESE |

## Top Applicants

- Mentor Corp. — 2 clearances

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

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