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510(k) Data Aggregation
K Number
K093785Device Name
MODULAR ENDOSCOPE
Manufacturer
SIALO TECHNOLOGY, LTD.
Date Cleared
2010-08-18
(252 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SIALO TECHNOLOGY, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Modular Endoscope is intended for use for visualization and to magnify and illuminate body cavities, hollow organs and canals in ENT procedures. The Modular Endoscope is intended for use for visualization and to magnify and illuminate dental surfaces. The Modular Endoscope is intended for using additional accessories to perform various diagnostic and therapeutic procedures in ENT surgery, including but not limited to, salivary gland diseases.
Device Description
The Modular Endoscope utilizes a fiberoptic technology to allow visualization of body cavities. The 6000/10,000 pixel optic system is semi rigid and is contained within a very small diameter of less than 1mm. The endoscope contains a working channel to allow access of various accessories for different therapeutic applications.
The Modular Endoscope is used with single use, multi port (2 or 3 port), sterile cannulas with diameters ranging from 0.9-2.3 mm, which provide the surgeon good flexibility in choosing the right equipment for the clinical procedure.
The single lumen cannula is inserted into the salivary gland or other body cavities or canals and serves as a working and irrigation channel, as well as containing the fiberoptic system. The fiberoptic system is protected from surgical tools and instruments by a nitinol coating.
An ocular is connected at the proximal end and light is transmitted via a light source cable from various commercially available Xenon lamp light sources to the optic system. The image can be visualized by connecting the endoscope to a camera and a monitor screen. The light source, camera and monitor are user-supplied.
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K Number
K082735Device Name
STONE GRASPING BASKET, MODEL PD-T1 2115
Manufacturer
SIALO TECHNOLOGY, LTD.
Date Cleared
2009-03-13
(176 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SIALO TECHNOLOGY, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stone Grasping Basket is a medical device indicated for use by qualified surgeons in the treatment of salivary gland diseases. It is used endoscopically to entrap and remove mobile stones and stone fragments smaller than 5mm from the salivary gland.
Device Description
The stone grasping basket is a 30mm long, 4 wire, 10mm Nitinol Stone removal Basket, which is designed to pass through low diameter working channels of endoscopes for the purpose of retrieval of stones from the salivary gland.
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K Number
K072334Device Name
SIALO DRAIN
Manufacturer
SIALO TECHNOLOGY, LTD.
Date Cleared
2008-07-18
(333 days)
Product Code
OAJ
Regulation Number
878.4200Why did this record match?
Applicant Name (Manufacturer) :
SIALO TECHNOLOGY, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sialo Drain is a medical device for use by qualified surgeons in the treatment of salivary gland diseases for the purpose of drainage.
The Sialo Drain is an intraoral/extraoral drainage catheter, intended to allow continuous drainage of saliva and/or fluid irrigation of the salivary duct by temporary insertion into the salivary gland, whether orally or through the cheek.
Device Description
The Sialo drain is a flexible, single lumen, sterile, single use, disposable cannula made of biocompatible radio-opaque polyurethane material.
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K Number
K072749Device Name
SIALO BALLOON DILATATION CATHETER
Manufacturer
SIALO TECHNOLOGY, LTD.
Date Cleared
2008-05-14
(230 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SIALO TECHNOLOGY, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sialo Balloon dilatation catheter is a medical device for use by qualified surgeons in the treatment of salivary gland diseases.
Device Description
The Sialo Balloon Dilatation Catheter is designed to allow dilatation of the salivary duct under endoscopic or radiological guidance. Dilatation can be therapeutic by itself (for duct strictures), or provide endoscopic access for stone removal.
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