Atlas FDA

MUU

40 FDA 510(k) clearances · Product code

142 daysmedian time to decision
272 days90th percentile
40clearances measured

FDA profile

Official device name
System, Suction, Lipoplasty
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5040
Medical specialty
General, Plastic Surgery
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).
Adverse events (MAUDE)
2018: 30 · 2019: 35 · 2020: 36 · 2021: 28 · 2022: 50 · 2023: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit (K210528)Millennium Medical Technologies Inc (Dba Cellmyx)2022-03-16
SyntrFuge System (K203800)Syntr Health Technologies, Inc.2021-07-02
Smart Kit Basic, Smart Kit Pro (K202443)Bsl Co., Ltd.2021-03-11
REVOLVE ENVI 600 Advanced Adipose System (K193539)Lifecell Corporation2020-05-28
Dermapose Refresh (K193363)Puregraft, LLC2020-04-14
JTL-250-01 (K182732)Jointechlabs, Inc.2019-11-18
Progenikine Concentrating System 25 mL System (K191564)Emcyte Corporation2019-11-07
KTA Adipose Treatment Kit (K190386)Stemics S.A.S2019-10-10
AuraGen 123 Suction Lipoplasty System (A123) (K190278)Auragen Aesthetics, LLC2019-05-03
Automatic Tissue Processing Unit (K172717)Bsl Co.2018-05-25
LipiVage (K172714)Genesis Biosystems, Inc.2017-12-08
Revolve Envi 600 Advanced Adipose System (K163647)Lifecell Corporation2017-08-25
Alma LipoFlow System (K171242)Alma Lasers, Inc.2017-07-14
Lipogems System (K171135)Lipogems International Spa2017-05-18
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 (K170449)Millennium Medical Technologies, Inc.2017-03-31
The Red Head Collection Device, The Jordy Connection System (K161372)Miami Fat Supply2017-02-24
Ranfac Fat Aspiration Cannula (K162932)Ranfac, Corp.2017-01-19
Lipogems System (K161636)Lipogems International Spa2016-11-04
Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel (K150156)Ranfac, Corp.2015-10-19
LipoFilter - Hospital Pack, LipoFilter - Clinic Pack (K150779)Microaire Surgical Instruments, LLC2015-05-22
ST'RIM (K142073)Thiebaud Sas2015-04-29
The Lipogems System (K142682)Lipogems International Spa2014-12-22
SMARTGRAFT 200 SYSTEM (K141713)Ingeneron, Inc.2014-10-28
SMARTGRAFT 30 SYSTEM (K141591)Ingeneron, Inc.2014-09-24
PUREGRAFT 50 SYSTEM (K132815)Cytori Therapeutics, Inc.2014-01-24
HYDRASOLVE LIPOPLASTY SYSTEM (K130152)Andrew Technologies, LLC2013-04-18
LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE (K121703)Medi-Khan USA, Inc.2012-12-07
ADIPREP ADIPOSE TRANSFER SYSTEM (K121005)Harvest Technologies, Corp.2012-09-21
ORIGINS LIPOHARVESTING SYSTEM (K120328)Sound Surgical Technologies, LLC2012-09-17
GID 700 (K120902)The Gid Group, Inc.2012-08-15
PUREGRAFT 850/PURE SYSTEM (K113255)Cytori Therapeutics, Inc.2012-03-07
FAT CONCENTRATION SYSTEM (K100114)Biomet, Inc.2010-09-29
TISSU TRANS FILTRON SYRINGE FILL (K102117)Shippert Medical Technologies Corp.2010-08-06
LIPCOLLECTOR II (K101713)Human Med AG2010-06-29
CYTORI PUREGRAFT 250/PURE SYSTEM (K092923)Cytori Therapeutics, Inc.2010-01-06
TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500 (K092482)Shippert Medical Technologies Corp.2009-12-04
LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200 (K092284)Medical Device Resource Corp.2009-09-01
LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100 (K083455)Medi-Khan USA, Inc.2009-05-18
LIPOSE FAT TRANSFER SYSTEM (K081848)Lipose Corp.2008-12-04
CYTORI AFT SYSTEM (K072587)Cytori Therapeutics, Inc.2007-12-10

Track MUU automatically

Every clearance here is in the API, with alerts when new ones post.