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510(k) Data Aggregation
K Number
K191564Device Name
Progenikine Concentrating System 25 mL System
Manufacturer
Emcyte Corporation
Date Cleared
2019-11-07
(147 days)
Product Code
MUU
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
Emcyte Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Progenikine Concentrating System is used in medical procedures involving the harvesting of autologous adipose tissue. The Progenikine® Concentrating System is used for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The Progenikine Concentrating System is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired.
Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic and Re-constructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Laparoscopic Surgery, Arthroscopic Surgery.
Device Description
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K Number
K183205Device Name
PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
Manufacturer
EmCyte Corporation
Date Cleared
2019-05-30
(192 days)
Product Code
JQC
Regulation Number
862.2050Why did this record match?
Applicant Name (Manufacturer) :
EmCyte Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PureBMC SupraPhysiologic Concentrating System is intended to be used in a clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet concentrate from a small sample of bone marrow aspirate. The safety and effectiveness of this device for in vivo indications for use has not been established.
Device Description
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