SEJ · Wound Dressings Containing Topical Analgesics
· Class U
Overview
| Product Code | SEJ |
|---|---|
| Device Name | Wound Dressings Containing Topical Analgesics |
| Device Class | Class U |
| Review Panel |
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 | 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 | ALLWOUND | At Squared, LLC | Jun 26, 2006 | SESE |
| K020540 | REGENECARE WOUND GEL | Mpm Medical., Inc. | Nov 1, 2002 | SESE |
| K001023 | FREEDOM, MODEL 4660 | Johnson & Johnson Consumer Companies, Inc. | Sep 22, 2000 | SESE |
| K922636 | HEMO-STAT | Mckinley-Ross Laboratories, Inc. | Nov 9, 1992 | SESE |
| K912565 | 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
