K210997 is an FDA 510(k) clearance for the PreferX Delivery System. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Md3, LLC (Coral Springs, US). The FDA issued a Cleared decision on September 7, 2021, 158 days after receiving the submission on April 2, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K210997 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2021 |
| Decision Date | September 07, 2021 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |