K152033 is an FDA 510(k) clearance for the Cook ECM Powder. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Cook Biotech Incorporated (West Lafayetta, US). The FDA issued a Cleared decision on August 19, 2015, 28 days after receiving the submission on July 22, 2015.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K152033 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2015 |
| Decision Date | August 19, 2015 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGN — Wound Dressing With Animal-derived Material(s) |
| Device Class | — |