K223526 is an FDA 510(k) clearance for the ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing. This device is classified as a Dressing, Wound, Drug.
Submitted by Smith & Nephew Medical Limited (Hull, GB). The FDA issued a Cleared decision on August 18, 2023, 268 days after receiving the submission on November 23, 2022.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K223526 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2022 |
| Decision Date | August 18, 2023 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |