K182838 is an FDA 510(k) clearance for the Geistlich Derma-Gide. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Geistlich Pharma AG (Wolhusen, CH). The FDA issued a Cleared decision on November 8, 2018, 30 days after receiving the submission on October 9, 2018.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K182838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2018 |
| Decision Date | November 08, 2018 |
| Days to Decision | 30 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 | — |