K173675 is an FDA 510(k) clearance for the AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber, a Dressing, Wound, Drug, submitted by Convatec Limited (Deeside, GB). The FDA issued a Cleared decision on July 20, 2018, 232 days after receiving the submission on November 30, 2017. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K173675 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 30, 2017 |
| Decision Date | July 20, 2018 |
| Days to Decision | 232 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |