MUU — System, Suction, Lipoplasty Class II
FDA product code MUU covers "System, Suction, Lipoplasty", a Class II medical device regulated under 21 CFR 878.5040. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |