510(k) BK220674
- Device
- Suction Lipoplasty System
- Applicant
- MicroAire Surgical Instruments, LLC.
- 510(k) number
- BK220674
- Product code
- MUU
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2022-03-16
- Date received
- 2022-02-14
- Regulation
- 878.5040
- Classification name
- System, Suction, Lipoplasty
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Clearance type
- 510(k) Special
- Third party reviewed
- No
Other 510(k) Records For Product Code MUU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K210528 | IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit | Millennium Medical Technologies Inc (Dba Cellmyx) | 2022-03-16 |
| K203800 | SyntrFuge System | Syntr Health Technologies, Inc. | 2021-07-02 |
| K202443 | Smart Kit Basic, Smart Kit Pro | Bsl Co., Ltd. | 2021-03-11 |
| K193539 | REVOLVE ENVI 600 Advanced Adipose System | Lifecell Corporation | 2020-05-28 |
| K193363 | Dermapose Refresh | Puregraft, LLC | 2020-04-14 |
| K182732 | JTL-250-01 | Jointechlabs, Inc. | 2019-11-18 |
| K191564 | Progenikine Concentrating System 25 mL System | Emcyte Corporation | 2019-11-07 |
| K190386 | KTA Adipose Treatment Kit | Stemics S.A.S | 2019-10-10 |
| K190278 | AuraGen 123 Suction Lipoplasty System (A123) | Auragen Aesthetics, LLC | 2019-05-03 |
| K172717 | Automatic Tissue Processing Unit | Bsl Co. | 2018-05-25 |
| K172714 | LipiVage | Genesis Biosystems, Inc. | 2017-12-08 |
| K163647 | Revolve Envi 600 Advanced Adipose System | Lifecell Corporation | 2017-08-25 |
| K171242 | Alma LipoFlow System | Alma Lasers, Inc. | 2017-07-14 |
| K171135 | Lipogems System | Lipogems International Spa | 2017-05-18 |
| K170449 | Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection | Millennium Medical Technologies, Inc. | 2017-03-31 |
Legacy Summary#
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FDA Review#
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