K150779 is an FDA 510(k) clearance for the LipoFilter - Hospital Pack, LipoFilter - Clinic Pack. This device is classified as a System, Suction, Lipoplasty (Class II - Special Controls, product code MUU).
Submitted by Microaire Surgical Instruments, LLC (Charlottesville, US). The FDA issued a Cleared decision on May 22, 2015, 58 days after receiving the submission on March 25, 2015.
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 | K150779 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2015 |
| Decision Date | May 22, 2015 |
| Days to Decision | 58 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). |