K231953 is an FDA 510(k) clearance for the Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in). This device is classified as a Dressing, Wound, Drug.
Submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on March 22, 2024, 266 days after receiving the submission on June 30, 2023.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K231953 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2023 |
| Decision Date | March 22, 2024 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |