K242146 is an FDA 510(k) clearance for the BIOBRANE Temporary Wound Dressing; BIOBRANE Glove, a Wound Dressing With Animal-derived Material(s), submitted by Smith & Nephew Medical Limited (Hull, GB). The FDA issued a Cleared decision on December 17, 2024, 147 days after receiving the submission on July 23, 2024. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K242146 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 23, 2024 |
| Decision Date | December 17, 2024 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGN — Wound Dressing With Animal-derived Material(s) |
| Device Class | — |