Product code SEJ
- Device name
- Wound Dressings Containing Topical Analgesics
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| 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. | 2009-07-30 |
| K053476 | ALLWOUND | At Squared, LLC | 2006-06-26 |
| K020540 | REGENECARE WOUND GEL | Mpm Medical., Inc. | 2002-11-01 |
| K001023 | FREEDOM, MODEL 4660 | Johnson & Johnson Consumer Companies, Inc. | 2000-09-22 |
| K922636 | HEMO-STAT | Mckinley-Ross Laboratories, Inc. | 1992-11-09 |
| K912565 | MICRO-COLL COLLAGEN WOUND SPRAY | Micro-Coll | 1992-06-11 |