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 Biomet, Inc., Bsl Co. and Jointechlabs, Inc..

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 Sep 29, 2010
FAT CONCENTRATION SYSTEM
K100114
Biomet, Inc.
General & Plastic Surgery · 257d

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.