K844228 is an FDA 510(k) clearance for the PDS POLYDIOXANONE MESH. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on January 24, 1985, 84 days after receiving the submission on November 1, 1984.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K844228 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1984 |
| Decision Date | January 24, 1985 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FTM — Mesh, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |