510(k) K092086
K092086 is an FDA 510(k) premarket notification submitted by Amerx Health Care Corp. for the device "AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027". The FDA issued a decision of Substantially Equivalent on July 30, 2009. The device falls under product code SEJ (Wound Dressings Containing Topical Analgesics), a Class U device. Amerx Health Care Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2009
- Date Received
- July 9, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Dressings Containing Topical Analgesics
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type
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.