K210528 is an FDA 510(k) clearance for the IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit. This device is classified as 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 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 | K210528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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). |