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) → EXE — Protector, Ostomy

# EXE · Protector, Ostomy

_Gastroenterology, Urology · 21 CFR 876.5900 · Class 1_

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

## Overview

- **Product Code:** EXE
- **Device Name:** Protector, 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K904233](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXE/K904233.md) | CONVATEC ABSORBENT BANDAGE | Convatec, A Division of E.R. Squibb & Sons | Mar 6, 1991 | SESE |
| [K770982](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXE/K770982.md) | UNITED SKIN BARRIER | Howmedica Corp. | Jul 15, 1977 | SESE |
| [K760927](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXE/K760927.md) | STOMA SHIELD ADAPTER | Rudolfo T. Sanchez | Jan 26, 1977 | SESE |

## Top Applicants

- Convatec, A Division of E.R. Squibb & Sons — 1 clearance
- Howmedica Corp. — 1 clearance
- Rudolfo T. Sanchez — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com