K210528 is an FDA 510(k) clearance for the IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit, a System, Suction, Lipoplasty (Class II — Special Controls, product code MUU), submitted by Millennium Medical Technologies Inc (Dba Cellmyx) (Carlsbad, US). The FDA issued a Cleared decision on March 16, 2022, 386 days after receiving the submission on February 23, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5040.
| 510(k) Number | K210528 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 23, 2021 |
| Decision Date | March 16, 2022 |
| Days to Decision | 386 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). |