K233378 is an FDA 510(k) clearance for the ABCcolla® Collagen ADM Scaffold. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Acro Biomedical Co., Ltd. (Kaohsiung City, TW). The FDA issued a Cleared decision on October 18, 2024, 382 days after receiving the submission on October 2, 2023.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K233378 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2023 |
| Decision Date | October 18, 2024 |
| Days to Decision | 382 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 | - |