K152926 is an FDA 510(k) clearance for the AQUACEL Ag Surgical SP Dressing. This device is classified as a Dressing, Wound, Drug.
Submitted by Convatec Limited (Deeside, GB). The FDA issued a Cleared decision on January 21, 2016, 108 days after receiving the submission on October 5, 2015.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K152926 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 2015 |
| Decision Date | January 21, 2016 |
| Days to Decision | 108 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |