K123481 is an FDA 510(k) clearance for the AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE. This device is classified as a Dressing, Wound, Drug.
Submitted by Convatec, Inc. (Skillman, US). The FDA issued a Cleared decision on June 6, 2013, 205 days after receiving the submission on November 13, 2012.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K123481 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2012 |
| Decision Date | June 06, 2013 |
| Days to Decision | 205 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |