K203800 is an FDA 510(k) clearance for the SyntrFuge System, a System, Suction, Lipoplasty (Class II — Special Controls, product code MUU), submitted by Syntr Health Technologies, Inc. (Irvine, US). The FDA issued a Cleared decision on July 2, 2021, 186 days after receiving the submission on December 28, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5040.
| 510(k) Number | K203800 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 28, 2020 |
| Decision Date | July 02, 2021 |
| Days to Decision | 186 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| 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). |