# SEJ · Wound Dressings Containing Topical Analgesics

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/productcode/SEJ

## Overview

- **Product Code:** SEJ
- **Device Name:** Wound Dressings Containing Topical Analgesics
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)

## Identification

A solid wound dressing containing topical analgesics is used to cover and protect a wound, to absorb exudate, to maintain appropriate moisture balance within the wound, and to reduce pain. A wound dressing formulated as a gel, cream or ointment containing topical analgesics is used to maintain appropriate moisture balance within the wound and to reduce pain.

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K092086](/device/K092086.md) | AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027 | Amerx Health Care Corp. | Jul 30, 2009 | SESE |
| [K053476](/device/K053476.md) | ALLWOUND | At Squared, LLC | Jun 26, 2006 | SESE |
| [K020540](/device/K020540.md) | REGENECARE WOUND GEL | Mpm Medical., Inc. | Nov 1, 2002 | SESE |
| [K001023](/device/K001023.md) | FREEDOM, MODEL 4660 | Johnson & Johnson Consumer Companies, Inc. | Sep 22, 2000 | SESE |
| [K922636](/device/K922636.md) | HEMO-STAT | Mckinley-Ross Laboratories, Inc. | Nov 9, 1992 | SESE |
| [K912565](/device/K912565.md) | MICRO-COLL COLLAGEN WOUND SPRAY | Micro-Coll | Jun 11, 1992 | SESE |

## Top Applicants

- Amerx Health Care Corp. — 1 clearance
- At Squared, LLC — 1 clearance
- Johnson & Johnson Consumer Companies, Inc. — 1 clearance
- Mckinley-Ross Laboratories, Inc. — 1 clearance
- Micro-Coll — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/SEJ](https://fda.innolitics.com/productcode/SEJ)

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