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510(k) Data Aggregation
K Number
K182732Device Name
JTL-250-01
Manufacturer
Jointechlabs, Inc.
Date Cleared
2019-11-18
(416 days)
Product Code
MUU
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
Jointechlabs, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The JTL Tissue Processing Device is a sterile medical device intended for the processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.
Device Description
The JTL-250-01 Tissue Processing Device is a centrifuge tube for processing lipoaspirate fat tissue that is intended for autologous homofunctional implant (lipofilling). The device is a pre-assembled, single-use centrifuge tube composed of a collection upper chamber, intermediate chamber, and a lower chamber. The diameter of the JTL Tissue Processing Device is 4.2 inches at the top ring and 3.6 inches in the main body. It stands 4 inches tall. The device weighs less than 1 pound. The components of the device are made of biocompatible materials. The device is sterilized by radiation and is intended for single use only. The JTL Tissue Processing Device is to be used in a healthcare facility. It is to be used and in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible.
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