Product code MUU
- Device name
- System, Suction, Lipoplasty
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.5040
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- 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).
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 ove... | Millennium Medical Technologies, Inc. | 2017-03-31 |
| K161372 | The Red Head Collection Device, The Jordy Connection System | Miami Fat Supply | 2017-02-24 |
| K162932 | Ranfac Fat Aspiration Cannula | Ranfac, Corp. | 2017-01-19 |
| K161636 | Lipogems System | Lipogems International Spa | 2016-11-04 |
| K150156 | Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel | Ranfac, Corp. | 2015-10-19 |
| K150779 | LipoFilter - Hospital Pack, LipoFilter - Clinic Pack | Microaire Surgical Instruments, LLC | 2015-05-22 |
| K142073 | ST'RIM | Thiebaud Sas | 2015-04-29 |
| K142682 | The Lipogems System | Lipogems International Spa | 2014-12-22 |
| K141713 | SMARTGRAFT 200 SYSTEM | Ingeneron, Inc. | 2014-10-28 |
| K141591 | SMARTGRAFT 30 SYSTEM | Ingeneron, Inc. | 2014-09-24 |
| K132815 | PUREGRAFT 50 SYSTEM | Cytori Therapeutics, Inc. | 2014-01-24 |
| K130152 | HYDRASOLVE LIPOPLASTY SYSTEM | Andrew Technologies, LLC | 2013-04-18 |
| K121703 | LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE | Medi-Khan USA, Inc. | 2012-12-07 |
| K121005 | ADIPREP ADIPOSE TRANSFER SYSTEM | Harvest Technologies, Corp. | 2012-09-21 |
| K120328 | ORIGINS LIPOHARVESTING SYSTEM | Sound Surgical Technologies, LLC | 2012-09-17 |
| K120902 | GID 700 | The Gid Group, Inc. | 2012-08-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07612367000109 | Silicone tubing ID 6.5mm, 180cm, 1 coupling piece | Medela AG | 2024-05-31 |
| 07612367003902 | Tubing holder right side | Medela AG | 2024-05-31 |
| 07612367003896 | Tubing holder left side | Medela AG | 2024-05-31 |
| 07612367003742 | Safety Set for railholder | Medela AG | 2024-05-31 |
| 07612367003735 | Reusable serial connector | Medela AG | 2024-05-31 |
| 07612367003698 | Overflow protection device | Medela AG | 2024-05-31 |
| 07612367003568 | Quiver 480mm | Medela AG | 2024-05-31 |
| 07612367003551 | Quiver 280mm | Medela AG | 2024-05-31 |
| 07612367003681 | Clip for Lid | Medela AG | 2021-08-12 |
| 07612367003582 | Disposable Specimen Cup | Medela AG | 2016-12-05 |
| 07612367002677 | Suction jar polysulfone 0.25l | Medela AG | 2016-10-24 |
| 07612367002820 | Small lid with conical patient connection and overflow protection device | Medela AG | 2016-10-24 |
| 07612367002684 | Suction jar polysulfone, 0.5l | Medela AG | 2016-10-24 |
| 07612367002691 | Suction Jar Polysulfone, 1l | Medela AG | 2016-10-24 |
| 07612367002707 | Suction jar polysulfone 2l | Medela AG | 2016-10-24 |
| 07612367002714 | Suction jar polysulfone 3l | Medela AG | 2016-10-24 |
| 07612367002721 | Suction jar polysulfone 5l | Medela AG | 2016-10-24 |
| 07612367002806 | Large lid with conical patient connection 6–10 mm | Medela AG | 2016-10-24 |
| 07612367002813 | Large lid with conical patient connection 10–14 mm | Medela AG | 2016-10-24 |
| 07612367002837 | Lid for safety Set with overflow protection device | Medela AG | 2016-10-24 |
| 07612367003957 | Disposable overflow protection / bacteria filter | Medela AG | 2016-10-03 |
| 07612367004138 | Safety device plugged into pump | Medela AG | 2016-10-03 |
| 07612367004152 | Disposable overflow protection / bacteria filter | Medela AG | 2016-10-03 |
| 07612367004169 | Disposable bacteria filter | Medela AG | 2016-10-03 |
| 07612367004183 | Disposable bacteria / odour filter | Medela AG | 2016-10-03 |
| 07612367004237 | Silicone tubing | Medela AG | 2016-10-03 |
| 07612367004244 | Silicone tubing | Medela AG | 2016-10-03 |
| 07612367004251 | Silicone tubing | Medela AG | 2016-10-03 |
| 07612367004268 | Silicone tubing | Medela AG | 2016-10-03 |
| 07612367003599 | Change-over valve with clampholder and tubing set | Medela AG | 2016-09-24 |