SEJ — Wound Dressings Containing Topical Analgesics Class U
Classification Details
- Product Code
- SEJ
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Unknown
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K092086 | amerx health care | AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), | July 30, 2009 |
| K053476 | at squared | ALLWOUND | June 26, 2006 |
| K020540 | mpm medical | REGENECARE WOUND GEL | November 1, 2002 |
| K001023 | johnson and johnson consumer companies | FREEDOM, MODEL 4660 | September 22, 2000 |
| K922636 | mckinley-ross laboratories | HEMO-STAT | November 9, 1992 |
| K912565 | micro-coll | MICRO-COLL COLLAGEN WOUND SPRAY | June 11, 1992 |