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510(k) Data Aggregation
K Number
K141713Device Name
SMARTGRAFT 200 SYSTEM
Manufacturer
Date Cleared
2014-10-28
(125 days)
Product Code
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
INGENERON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SmartGraft™ 200 system is intended to be used in medical procedures involving the harvesting, centrifugation and transferring of autologous adipose tissue. The SmartGraft™ 200 system is used for concentrating adipose tissue for aesthetic body contouring, and for tissue that has been harvested with a legally marketed lipoplasty system.
The SmartGraft™ 200 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 Reconstructive Surgery,
- · General Surgery,
- · Orthopedic Surgery,
- · Gynecological Surgery,
- · Thoracic Surgery,
- · Laparoscopic Surgery, and
- · Arthroscopic Surgery
Device Description
The SmartGraft™ 200 System is a disposable process pack to be used with the InGeneron Tissue Processing Unit (centrifuge). The process pack is a collection of sterile single-use off-the-shelf and proprietary components used during the process of harvesting, centrifugation, and transferring of autologous adipose tissue. It is intended for the concentration of aspirated adipose tissue for subsequent transfer during the same procedure.
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K Number
K141591Device Name
SMARTGRAFT 30 SYSTEM
Manufacturer
Date Cleared
2014-09-24
(103 days)
Product Code
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
INGENERON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SmartGraft™ 30 system is intended to be used in medical procedures involving the harvesting, centrifugation and transferring of autologous adipose tissue. The SmartGraff™ 30 system is used for concentrating adipose tissue for aesthetic body contouring, and for tissue that has been harvested with a legally marketed lipoplasty system.
The SmartGraft™ 30 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 Reconstructive Surgery,
- · General Surgery,
- · Orthopedic Surgery,
- · Gynecological Surgery,
- · Thoracic Surgery,
- · Laparoscopic Surgery,
- · Arthroscopic Surgery
Device Description
The SmartGraft™ 30 System is a disposable process pack to be used with the InGeneron Tissue Processing Unit (centrifuge). The process pack is a collection of sterile single-use off-the-shelf and proprietary components used during the process of harvesting, centrifugation and transferring of autologous adipose tissue. It is intended for the concentration of aspirated adipose tissue for subsequent transfer during the same procedure.
Ask a Question
Ask a specific question about this device
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