Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4022](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4022) → PXQ — Burn Dressing Tray

# PXQ · Burn Dressing Tray

_General, Plastic Surgery · 21 CFR 878.4022 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PXQ

## Overview

- **Product Code:** PXQ
- **Device Name:** Burn Dressing Tray
- **Regulation:** [21 CFR 878.4022](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4022)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PXQ](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PXQ)

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