System, Suction, Lipoplasty
MUU is the FDA product code for System, Suction, Lipoplasty, a class II device type, regulated under 21 CFR 878.5040. FDA's definition for this code reads: "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)". As of , FDA records hold 40 510(k) clearances under this code, the most recent dated , and 15 recalls.
Classification record
- Product code
- MUU
- Device name
- System, Suction, Lipoplasty
- FDA 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).
- Regulation
- 21 CFR 878.5040
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 40
- Ingested recalls
- 15
Clearances, product code MUU
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 3 |
| 2010 | 4 |
| 2012 | 5 |
| 2013 | 1 |
| 2014 | 4 |
| 2015 | 3 |
| 2016 | 1 |
| 2017 | 7 |
| 2018 | 1 |
| 2019 | 4 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 1 |
Applicants with the most clearances
Product code MUU| Applicant | Clearances |
|---|---|
| Cytori Therapeutics, Inc. | 4 |
| Lipogems International S.p.A. | 3 |
| Bsl Co. | 2 |
| Ingeneron, Inc. | 2 |
| LifeCell Corp | 2 |
| Medi-Khan USA, Inc. | 2 |
| Ranfac Corp. | 2 |
| Summit Medical, LLC | 2 |
| Alma Lasers Ltd. | 1 |
| Andrew Technologies, LLC | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
