MUU — System, Suction, Lipoplasty Class II
Classification Details
- Product Code
- MUU
- Device Class
- Class II
- Regulation Number
- 878.5040
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K210528 | millennium medical technologies inc (dba cellmyx) | IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Bod | March 16, 2022 |
| K203800 | syntr health technologies | SyntrFuge System | July 2, 2021 |
| K202443 | bsl co | Smart Kit Basic, Smart Kit Pro | March 11, 2021 |
| K193539 | lifecell corporation | REVOLVE ENVI 600 Advanced Adipose System | May 28, 2020 |
| K193363 | puregraft | Dermapose Refresh | April 14, 2020 |
| K182732 | jointechlabs | JTL-250-01 | November 18, 2019 |
| K191564 | emcyte corporation | Progenikine Concentrating System 25 mL System | November 7, 2019 |
| K190386 | stemics | KTA Adipose Treatment Kit | October 10, 2019 |
| K190278 | auragen aesthetics | AuraGen 123 Suction Lipoplasty System (A123) | May 3, 2019 |
| K172717 | bsl | Automatic Tissue Processing Unit | May 25, 2018 |
| K172714 | genesis biosystems | LipiVage | December 8, 2017 |
| K163647 | lifecell corporation | Revolve Envi 600 Advanced Adipose System | August 25, 2017 |
| K171242 | alma lasers | Alma LipoFlow System | July 14, 2017 |
| K171135 | lipogems international | Lipogems System | May 18, 2017 |
| K170449 | millennium medical technologies | Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3 | March 31, 2017 |
| K161372 | miami fat supply | The Red Head Collection Device, The Jordy Connection System | February 24, 2017 |
| K162932 | ranfac | Ranfac Fat Aspiration Cannula | January 19, 2017 |
| K161636 | lipogems international | Lipogems System | November 4, 2016 |
| K150156 | ranfac | Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspirat | October 19, 2015 |
| K150779 | microaire surgical instruments | LipoFilter - Hospital Pack, LipoFilter - Clinic Pack | May 22, 2015 |