K182259 is an FDA 510(k) clearance for the Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by Acell, Inc. (Columbia, US). The FDA issued a Cleared decision on February 7, 2019, 170 days after receiving the submission on August 21, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K182259 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2018 |
| Decision Date | February 07, 2019 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTM — Mesh, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |