K191564 is an FDA 510(k) clearance for the Progenikine Concentrating System 25 mL System. This device is classified as a System, Suction, Lipoplasty (Class II - Special Controls, product code MUU).
Submitted by Emcyte Corporation (Fort Meyers, US). The FDA issued a Cleared decision on November 7, 2019, 147 days after receiving the submission on June 13, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5040. See Federal Register Notice At 86 Fr 50887 ?consolidation Of Devices That Process Autologous Human Cells, Tissues, And Cellular And Tissue-based Products At The Point Of Care To Produce A Therapeutic Article? (frn) (fda-2021-n-0881)..
| 510(k) Number | K191564 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2019 |
| Decision Date | November 07, 2019 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | MUU — System, Suction, Lipoplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5040 |
| Definition | See Federal Register Notice At 86 Fr 50887 ?consolidation Of Devices That Process Autologous Human Cells, Tissues, And Cellular And Tissue-based Products At The Point Of Care To Produce A Therapeutic Article? (frn) (fda-2021-n-0881). |