510(k) K203800

Device
SyntrFuge System
Applicant
Syntr Health Technologies, Inc.
510(k) number
K203800
Product code
MUU
Decision
Substantially Equivalent (SESE)
Decision date
2021-07-02
Date received
2020-12-28
Regulation
878.5040
Classification name
System, Suction, Lipoplasty
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Ahmed Zobi
Address
5270 California Ave. Suite 300 Irvine CA US 92617 92617

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code MUU

510(k)DeviceApplicantDecision date
K210528IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) KitMillennium Medical Technologies Inc (Dba Cellmyx)2022-03-16
K202443Smart Kit Basic, Smart Kit ProBsl Co., Ltd.2021-03-11
K193539REVOLVE ENVI 600 Advanced Adipose SystemLifecell Corporation2020-05-28
K193363Dermapose RefreshPuregraft, LLC2020-04-14
K182732JTL-250-01Jointechlabs, Inc.2019-11-18
K191564Progenikine Concentrating System 25 mL SystemEmcyte Corporation2019-11-07
K190386KTA Adipose Treatment KitStemics S.A.S2019-10-10
K190278AuraGen 123 Suction Lipoplasty System (A123)Auragen Aesthetics, LLC2019-05-03
K172717Automatic Tissue Processing UnitBsl Co.2018-05-25
K172714LipiVageGenesis Biosystems, Inc.2017-12-08
K163647Revolve Envi 600 Advanced Adipose SystemLifecell Corporation2017-08-25
K171242Alma LipoFlow SystemAlma Lasers, Inc.2017-07-14
K171135Lipogems SystemLipogems International Spa2017-05-18
K170449Autoclavable 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 protectionMillennium Medical Technologies, Inc.2017-03-31
K161372The Red Head Collection Device, The Jordy Connection SystemMiami Fat Supply2017-02-24