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) → PQE — Ostomy Care Kit

# PQE · Ostomy Care Kit

_Gastroenterology, Urology · 21 CFR 876.5900 · Class 1_

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

## Overview

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

## Identification

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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