MUU · Class II · 21 CFR 878.5040

FDA Product Code MUU: System, Suction, Lipoplasty

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).

Leading manufacturers include Cytori Therapeutics, Inc., Lipogems International Spa and Ranfac, Corp..

40
Total
40
Cleared
154d
Avg days
2007
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared System, Suction, Lipoplasty Devices (Product Code MUU)

40 devices
1–24 of 40
Cleared Mar 16, 2022
IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit
K210528
Millennium Medical Technologies Inc (Dba Cellmyx)
General & Plastic Surgery · 386d
Cleared Jul 02, 2021
SyntrFuge System
K203800
Syntr Health Technologies, Inc.
General & Plastic Surgery · 186d
Cleared Mar 11, 2021
Smart Kit Basic, Smart Kit Pro
K202443
Bsl Co., Ltd.
General & Plastic Surgery · 197d
Cleared May 28, 2020
REVOLVE ENVI 600 Advanced Adipose System
K193539
Lifecell Corporation
General & Plastic Surgery · 160d
Cleared Apr 14, 2020
Dermapose Refresh
K193363
Puregraft, LLC
General & Plastic Surgery · 132d
Cleared Nov 18, 2019
JTL-250-01
K182732
Jointechlabs, Inc.
General & Plastic Surgery · 416d
Cleared Nov 07, 2019
Progenikine Concentrating System 25 mL System
K191564
Emcyte Corporation
General & Plastic Surgery · 147d
Cleared Oct 10, 2019
KTA Adipose Treatment Kit
K190386
Stemics S.A.S
General & Plastic Surgery · 233d
Cleared May 03, 2019
AuraGen 123 Suction Lipoplasty System (A123)
K190278
Auragen Aesthetics, LLC
General & Plastic Surgery · 84d
Cleared May 25, 2018
Automatic Tissue Processing Unit
K172717
Bsl Co.
General & Plastic Surgery · 259d
Cleared Dec 08, 2017
LipiVage
K172714
Genesis Biosystems, Inc.
General & Plastic Surgery · 91d
Cleared Aug 25, 2017
Revolve Envi 600 Advanced Adipose System
K163647
Lifecell Corporation
General & Plastic Surgery · 245d
Cleared Jul 14, 2017
Alma LipoFlow System
K171242
Alma Lasers, Inc.
General & Plastic Surgery · 78d
Cleared May 18, 2017
Lipogems System
K171135
Lipogems International Spa
General & Plastic Surgery · 31d
Cleared Mar 31, 2017
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.
General & Plastic Surgery · 44d
Cleared Feb 24, 2017
The Red Head Collection Device, The Jordy Connection System
K161372
Miami Fat Supply
General & Plastic Surgery · 283d
Cleared Jan 19, 2017
Ranfac Fat Aspiration Cannula
K162932
Ranfac, Corp.
General & Plastic Surgery · 91d
Cleared Nov 04, 2016
Lipogems System
K161636
Lipogems International Spa
General & Plastic Surgery · 143d
Cleared Oct 19, 2015
Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel
K150156
Ranfac, Corp.
General & Plastic Surgery · 269d
Cleared May 22, 2015
LipoFilter - Hospital Pack, LipoFilter - Clinic Pack
K150779
Microaire Surgical Instruments, LLC
General & Plastic Surgery · 58d
Cleared Apr 29, 2015
ST'RIM
K142073
Thiebaud Sas
General & Plastic Surgery · 272d
Cleared Dec 22, 2014
The Lipogems System
K142682
Lipogems International Spa
General & Plastic Surgery · 94d
Cleared Oct 28, 2014
SMARTGRAFT 200 SYSTEM
K141713
Ingeneron, Inc.
General & Plastic Surgery · 125d
Cleared Sep 24, 2014
SMARTGRAFT 30 SYSTEM
K141591
Ingeneron, Inc.
General & Plastic Surgery · 103d

About Product Code MUU - Regulatory Context

510(k) Submission Activity

40 total 510(k) submissions under product code MUU since 2007, with 40 receiving FDA clearance (average review time: 154 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.