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 Ingeneron, Inc..

40
Total
40
Cleared
154d
Avg days
2007
Since
40 devices
25–40 of 40
Cleared Jan 24, 2014
PUREGRAFT 50 SYSTEM
K132815
Cytori Therapeutics, Inc.
General & Plastic Surgery · 137d
Cleared Apr 18, 2013
HYDRASOLVE LIPOPLASTY SYSTEM
K130152
Andrew Technologies, LLC
General & Plastic Surgery · 86d
Cleared Dec 07, 2012
LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE
K121703
Medi-Khan USA, Inc.
General & Plastic Surgery · 182d
Cleared Sep 21, 2012
ADIPREP ADIPOSE TRANSFER SYSTEM
K121005
Harvest Technologies, Corp.
General & Plastic Surgery · 171d
Cleared Sep 17, 2012
ORIGINS LIPOHARVESTING SYSTEM
K120328
Sound Surgical Technologies, LLC
General & Plastic Surgery · 228d
Cleared Aug 15, 2012
GID 700
K120902
The Gid Group, Inc.
General & Plastic Surgery · 142d
Cleared Mar 07, 2012
PUREGRAFT 850/PURE SYSTEM
K113255
Cytori Therapeutics, Inc.
General & Plastic Surgery · 125d
Cleared Sep 29, 2010
FAT CONCENTRATION SYSTEM
K100114
Biomet, Inc.
General & Plastic Surgery · 257d
Cleared Aug 06, 2010
TISSU TRANS FILTRON SYRINGE FILL
K102117
Shippert Medical Technologies Corp.
General & Plastic Surgery · 9d
Cleared Jun 29, 2010
LIPCOLLECTOR II
K101713
Human Med AG
General & Plastic Surgery · 11d
Cleared Jan 06, 2010
CYTORI PUREGRAFT 250/PURE SYSTEM
K092923
Cytori Therapeutics, Inc.
General & Plastic Surgery · 105d
Cleared Dec 04, 2009
TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500
K092482
Shippert Medical Technologies Corp.
General & Plastic Surgery · 113d
Cleared Sep 01, 2009
LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200
K092284
Medical Device Resource Corp.
General & Plastic Surgery · 34d
Cleared May 18, 2009
LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100
K083455
Medi-Khan USA, Inc.
General & Plastic Surgery · 178d
Cleared Dec 04, 2008
LIPOSE FAT TRANSFER SYSTEM
K081848
Lipose Corp.
General & Plastic Surgery · 157d
Cleared Dec 10, 2007
CYTORI AFT SYSTEM
K072587
Cytori Therapeutics, Inc.
General & Plastic Surgery · 87d