FDA product code MUU: System, Suction, Lipoplasty
MUU is the FDA product code for system, suction, lipoplasty. It is a Class II device, regulated under 21 CFR 878.5040 and reviewed by the General and Plastic Surgery panel. FDA has cleared 40 510(k) submissions under MUU, 1 in the last five years, from 30 different applicants. The average 510(k) review took 154 days (median 140). FDA has posted 15 recalls for MUU devices.
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).
Classification
| Field | Value |
|---|---|
| Device name | System, Suction, Lipoplasty |
| Device class | Class II |
| Regulation | 21 CFR 878.5040 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for MUU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 7 | 123 |
| 2018 | 1 | 259 |
| 2019 | 4 | 220 |
| 2020 | 2 | 146 |
| 2021 | 2 | 192 |
| 2022 | 1 | 386 |
Compare with all 510(k) review times · Search every MUU clearance
Top MUU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cytori Therapeutics, Inc. | 4 | 2014-01-24 |
| Lipogems International Spa | 3 | 2017-05-18 |
| Lifecell Corporation | 2 | 2020-05-28 |
| Ranfac, Corp. | 2 | 2017-01-19 |
| Ingeneron, Inc. | 2 | 2014-10-28 |
25 more applicants have MUU clearances. See the full list in Caduvo.
Most recent MUU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K210528 | Millennium Medical Technologies Inc (Dba Cellmyx) | IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit | 2022-03-16 | 386 |
| K203800 | Syntr Health Technologies, Inc. | SyntrFuge System | 2021-07-02 | 186 |
| K202443 | Bsl Co., Ltd. | Smart Kit Basic, Smart Kit Pro | 2021-03-11 | 197 |
| K193539 | Lifecell Corporation | REVOLVE ENVI 600 Advanced Adipose System | 2020-05-28 | 160 |
| K193363 | Puregraft, LLC | Dermapose Refresh | 2020-04-14 | 132 |
Recalls for MUU devices
15 product recalls in 8 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-02-02.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 7 |
Frequently asked questions
What is FDA product code MUU?
MUU is the FDA product code for system, suction, lipoplasty. It is a Class II device, regulated under 21 CFR 878.5040 and reviewed by the General and Plastic Surgery panel.
What device class is MUU?
Class II, regulation 21 CFR 878.5040. Typical premarket route: 510(k).
How long does a 510(k) take for product code MUU?
Across 40 cleared submissions the average was 154 days from receipt to decision (median 140).
Which companies have the most MUU clearances?
Cytori Therapeutics, Inc. (4); Lipogems International Spa (3); Lifecell Corporation (2); Ranfac, Corp. (2); Ingeneron, Inc. (2).
Have MUU devices been recalled?
Yes: 15 product recalls across 8 recall events; the most recent began 2018-02-02.
Next steps
- Run an FDA pathway report with predicate devices for product code MUU
- Run a recall and safety report across every MUU manufacturer
- Watch product code MUU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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